Drug Substance (CDMO/CRO)
Drug Product (CMO)

Find and compare companies providing:
Contract pharmaceutical outsourcing services


Filter by expertise, certification, scale and geography to shortlist trusted contract pharmaceutical service providers for effective pharma outsourcing.

HIGHLIGHTED

Located in:

Germany

Plants in:

Germany

Established in: 2008

Production scale:

large

small

medium

Employees: 4.000

With 14 production sites in Europe and the USA

7 Development Centers of Excellence covering all dosage forms

13 locations with Technology Services on site for seamless Tech Transfer and product Life-Cycle Management

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

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HIGHLIGHTED

Located in:

India

Plants in:

India

Established in: 1998

Production scale:

small

medium

large

Employees: 1000

Facilities with global regulatory compliance

Customized and Flexible Collaboration Models

End-to-end drug discovery

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

  • ema

Replies quickly

HIGHLIGHTED

Located in:

Poland

Plants in:

Poland

Production scale:

small

medium

large

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • ema

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HIGHLIGHTED

Located in:

United States

Plants in:

GermanyFranceGreeceSwitzerlandNorwayJapan

Production scale:

large

medium

small

Specialized in complex product development and manufacturing.

High-quality standards with a focus on customer-specific needs.

Agile and innovative approach to CDMO services.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

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HIGHLIGHTED

Located in:

Germany

Plants in:

Germany

Established in: 1886

Production scale:

medium

small

Employees: 275+

Raw materials, CMO and OTC products

Two GMP certified locations

Customisable (small-sized) packages

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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HIGHLIGHTED

Located in:

India

Plants in:

India

Established in: 2023

Production scale:

small

medium

large

Employees: 1000+

Expertise in Conventional, Complex, and Niche Chemistries

End-to-end Support from early development to Commercial Phases

Comprehensive Analytical Support Facilities

  • GMP

  • FDA

  • EMA

All certificates

  • fda

  • ema

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HIGHLIGHTED

Located in:

United States

Plants in:

United States

Established in: 1975

Production scale:

small

medium

large

Employees: 234

45+ years of experience in oral solid and nonsterile oral liquid

Specialization in pediatric, geriatric, and controlled-substance

Reliable and flexible full-service production partner

  • GMP

  • FDA

  • EMA

All certificates

  • fda

  • gmp

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Plants in:

Switzerland

Established in: 1964

Production scale:

small

medium

large

Employees: 135+

Market leader in Switzerland

Small and medium batch sizes

Pharmaceutical raw materials with a herbal or synthetic basis

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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Plants in:

India

Established in: 2021

Production scale:

small

Employees: 19

API, Intermediates, Building Blocks, Impurities, Amino acids and Peptides

Small quantity APIs to commercial scale

GMP and USFDA certification based on quantity, order, assignment.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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Plants in:

Latvia

Established in: 1972

Production scale:

medium

Employees: 1,000+

EU-GMP for APIs and CEP for certain APIs

Exporting to over 50 countries worldwide

Long-standing technological advantage in adamantane, quinuclidine and nitrofurane chemistry

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

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Plants in:

ItalyPortugal

Established in: 1993

Production scale:

small

medium

large

Employees: 600

Integrated innovative platforms for Technology Transfer (TT&GO®)

Fermentation, purification, and chemical synthesis technologies on the same site

Scalability from Laboratory and Pilot to Industrial scales

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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Located in:

China

Plants in:

China

Established in: 2016

Production scale:

small

medium

large

Employees: 200

PFAS-Free Peptides

Certified Quality & Sustainability with ISO 9000 certification and RSPO audited supplier & GMP

Specialized in APIs & Pharmaceutical Intermediates

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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Plants in:

AustriaGermany

Established in: 1934

Production scale:

large

small

medium

Employees: 1500

Full-Service CDMO with End-to-End Solutions

Reliable Global Distribution Operating in over 70 countries

Specialized in hormones, crystal-suspensions and complex injectables

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • ema

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Located in:

Germany

Plants in:

Germany

Established in: 1982

Production scale:

small

Employees: 30+

Modern GMP facility

Team of academics and technical experts

Small to large batch sizes possible

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

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Plants in:

China

Established in: 2014

Production scale:

small

medium

large

Employees: 1000+

24 years of production experience

6 workshops and 9 production lines which has 100t/month production capacity

4 USDMFS & 8 CEPS & 200+ Patents

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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Located in:

United States

Plants in:

United States

Established in: 2010

Employees: 185

15 years of experience in synthetic chemistry, PhD & Master up to 50 employees

Logistics advantage: global customers can be delivered within 2-7 working days

Confidentiality Assured: With confidentiality clauses to ensure customer data security

  • GMP

  • FDA

  • EMA

All certificates

    Replies quickly

    Plants in:

    Germany

    Established in: 1980

    Production scale:

    medium

    Employees: 30+

    EU-GMP and DIN EN ISO 9001:2015

    Pioneer in the fractionation of sheep plasma

    Pure & sterile high-quality products

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

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    Plants in:

    China

    Established in: 2008

    Production scale:

    large

    medium

    Employees: 300+

    More than 150 patents based on independent intelligence

    Expertise in anti-tumor, anti-diabetes and cardiovascular API and intermediates.

    GMP facility with annual production capacity of 300M

    • GMP

    • FDA

    • EMA

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    • gmp

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    Located in:

    China

    Plants in:

    China

    Established in: 2003

    Production scale:

    large

    Employees: 4000+

    20+ years’ expertise in API manufacturing, trusted for quality and global compliance.

    Listed pharma leader in China, prioritizing transparency and regulatory excellence.

    End-to-end integration from R&D to scalable production, delivering cost-efficient solutions.

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

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    Located in:

    United Kingdom

    Plants in:

    United Kingdom

    Established in: 2006

    Production scale:

    small

    medium

    Employees: 20

    Quality Assurance: Products are manufactured from the finest raw materials and undergo rigorous testing.

    Tailored Customisation & Compliance: Providing end-to-end solutions to meet your business

    Dependable Expertise and Supply: Backed by years of industry experience and a robust supply chain.

    • GMP

    • FDA

    • EMA

    All certificates

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    Located in:

    India

    Plants in:

    India

    Established in: 2022

    Production scale:

    large

    Employees: 50

    Complex Chemistry Expertise – 30+ advanced chemistries backed by a strong R&D team

    End-to-End Molecule Development from Idea to Commercial Scale

    Global Quality, India Advantage – cGMP/FDA-compliant facilities, world-class SHE & IP standard at effecient pricing

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    • fda

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    Plants in:

    China

    Established in: 2013

    Production scale:

    medium

    Employees: 25+

    ISO9001 certified

    Drug R&D center (in Hangzhou)

    From lab scale (mg/g) to commercial scale (kgs/tons)

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies quickly

    Plants in:

    India

    Established in: 1989

    Production scale:

    large

    Employees: 5000+

    6 production facilities approved by USFDA, AGES-Austria, PMDA, WHO

    R&D Centers with capabilities of ANDAs, DMFs and NDDS

    462+ patents filed for drug substances and polymorphs

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    • fda

    Replies quickly

    Plants in:

    FranceBelgium

    Established in: 1952

    Production scale:

    small

    medium

    large

    Employees: 550+

    API manufacturing (Innovators, Generics and Highly Potent)

    A tailor-made and flexible service approach

    State-of-the-art analytical services including solid form and QbD laboratories

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    • fda

    Replies quickly

    Plants in:

    China

    Established in: 1987

    Production scale:

    medium

    small

    large

    Employees: 50+

    ISO 9001:2015 & SGS audited supplier

    One-stop CDMO Solutions for APl and Key intermediates

    Specialized in APIs & Pharmaceutical Intermediates for 38 years

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies quickly

    Located in:

    China

    Plants in:

    China

    Established in: 2012

    Production scale:

    medium

    Employees: 180

    A high-tech enterprise with 13 own patents granted

    Strong R&D system with ISO9001 / ISO14001 / OHSAS18001 certification

    Provide professional CMO & CDMO service

    • GMP

    • FDA

    • EMA

    All certificates

      Replies quickly

      Located in:

      Germany

      Plants in:

      Germany

      Established in: 1997

      Production scale:

      small

      medium

      Employees: 140

      Top-tier adherence to global pharmaceutical standards including GMP, FDA and EMA

      Specialized advanced chemistry laboratory focused on upscaling and GMP transfer processes

      Comprehensive analytical services to meet precise client specifications.

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      • fda

      • ema

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      Located in:

      China

      Plants in:

      China

      Established in: 2016

      Production scale:

      large

      Certified by US FDA

      Well-Established Environmental, Health & Safety Protocols

      Seasoned Project Execution Team

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      • fda

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      Plants in:

      Poland

      Established in: 1951

      Production scale:

      medium

      Employees: 455+

      Largest Polish manufacturer of pharmaceuticals and a leader of the Polish pharmaceutical market.

      FDA approved european manufcaturing facilities

      Export APIs to more than 60 countries worldwide

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      • fda

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      Plants in:

      Spain

      Established in: 1955

      Production scale:

      small

      medium

      large

      Employees: 500+

      BFS expertise with FDA Approval for Sterile Manufacturing

      USA and European Quality

      Innovative solutions for ophthalmology and otorhinolaryngology

      • GMP

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      All certificates

      • gmp

      • fda

      • ema

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      Plants in:

      United StatesIndiaFranceGermanyUnited KingdomSpainItaly

      Established in: 1991

      Production scale:

      small

      medium

      large

      Employees: 3,500+

      More than 12 GMP manufacturing facilities (EU, US, India)

      Portfolio of more than 240 commercial APIs

      We are experts in the cGMP production of highly potent compounds

      • GMP

      • FDA

      • EMA

      All certificates

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        Plants in:

        China

        Established in: 2019

        Production scale:

        large

        Employees: 10+

        Focused on pharmaceutical industry

        Reasonable price for the customers

        Full service from R&D stage to commercial stage

        • GMP

        • FDA

        • EMA

        All certificates

        • fda

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        Plants in:

        United States

        Established in: 2005

        Production scale:

        medium

        small

        Employees: 200+

        Portfolio of over 2,000 APIs

        Precise quality control

        End-to-end global regulatory support

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        Replies quickly

        Plants in:

        United States

        Established in: 2016

        Production scale:

        medium

        small

        Low Volume high value API Fill and Finish Service

        In-line monitoring, SKAN Isolators, Highly Experienced Staff

        Capacity Available, Ready for your API

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        Replies quickly

        Located in:

        United States

        Plants in:

        China

        Established in: 2006

        Production scale:

        small

        medium

        large

        Employees: 3500

        Silver EcoVadis awardee committed to sustainability

        Exceptional synthesis experience of HPAPIs

        One-stop CDMO Solutions for APl and Key intermediates

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        • fda

        Replies quickly

        Located in:

        Denmark

        Plants in:

        Denmark

        Established in: 1965

        Production scale:

        small

        medium

        large

        Employees: 600+

        Pharmaceutical-quality dextrans meeting the highest standards and complying with major pharmacopeias

        Manufactured in a cGMP facility in Denmark, inspected by both the FDA and EMA

        Documented quality and certifications from the US FDA and EDQM for smooth regulatory submission

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        • fda

        • ema

        Replies quickly

        Located in:

        Germany

        Plants in:

        Germany

        Established in: 1993

        Production scale:

        large

        Employees: 75

        Clinically proven efficacy

        Highest safety profile

        In-depth scientific & regulatory support

        • GMP

        • FDA

        • EMA

        All certificates

          Replies quickly

          Located in:

          Singapore

          Plants in:

          Singapore

          Established in: 2011

          Production scale:

          small

          Employees: 50+

          Comprehensive Product Portfolio with Competitive Pricing.

          Focus on Quality and Regulatory Compliance, One-stop, Responsive, End-to-End Service from R&D Through Commercialization.

          Expertise and Reliability in Pharmaceutical Material Supply, Backed by a Singaporean Presence.

          • GMP

          • FDA

          • EMA

          All certificates

          • gmp

          Replies quickly

          Located in:

          France

          Plants in:

          France

          Established in: 1962

          Production scale:

          large

          500 millions of lozenges per year at the Aignan site

          143 million packs per year at the Gien site

          252 formulations per year at the Cahors site

          • GMP

          • FDA

          • EMA

          All certificates

            Replies slower than most

            Located in:

            Germany

            Plants in:

            Germany

            Established in: 1950

            Excellence in aseptic filling and packaging solutions for biologics.

            Customized solutions for pre-filled syringes, vials, and cartridges.

            Strong track record in supporting global market launches.

            • GMP

            • FDA

            • EMA

            All certificates

              Replies slower than most

              Located in:

              Portugal

              Plants in:

              Portugal

              Established in: 2013

              Production scale:

              small

              medium

              Employees: 50

              Custom Fermentation Solutions, Strain Selection & Development

              Process optimization to maximize yield, efficiency, and product quality

              Support and scale-up expertise with consistent and reliable results each stage

              • GMP

              • FDA

              • EMA

              All certificates

                Replies quickly

                Plants in:

                United States

                Established in: 1942

                Production scale:

                large

                Over 100 unique marketed pharmaceutical products and 17 approved product applications since 2019

                Manufacturing capacities : 3.5B Oral Solid doses and 2.0M liters of liquids per year

                We specialize in contract manufacturing of Oral Solid Dose (OSD) and Liquids, including high potency substances and small molecules.

                • GMP

                • FDA

                • EMA

                All certificates

                  Replies slower than most

                  Located in:

                  United States

                  Plants in:

                  United States

                  Established in: 2002

                  Production scale:

                  large

                  Specialized in biologics CDMO services with a focus on monoclonal antibodies.

                  Advanced facilities for clinical and commercial-scale manufacturing.

                  Strong commitment to quality and regulatory compliance.

                  • GMP

                  • FDA

                  • EMA

                  All certificates

                  • gmp

                  • fda

                  Replies slower than most

                  Located in:

                  Spain

                  Plants in:

                  Spain

                  Established in: 1940

                  Production scale:

                  large

                  Leading global provider of plasma-derived medicines.

                  Strong focus on innovation in bioscience solutions.

                  Comprehensive services from plasma collection to finished product.

                  • GMP

                  • FDA

                  • EMA

                  All certificates

                    Replies slower than most

                    Located in:

                    Italy

                    Plants in:

                    Italy

                    Expertise in ophthalmic drug delivery solutions.

                    Committed to high-quality standards and patient safety.

                    Innovative R&D for advanced ophthalmic formulations.

                    • GMP

                    • FDA

                    • EMA

                    All certificates

                      Replies slower than most

                      Located in:

                      United States

                      Plants in:

                      United States

                      Leaders in dermatological product development and testing.

                      Innovative solutions for skin permeation and absorption studies.

                      Strong focus on client-centric, scientifically driven services.

                      • GMP

                      • FDA

                      • EMA

                      All certificates

                        Replies slower than most

                        Located in:

                        Germany

                        Plants in:

                        Germany

                        Established in: 1885

                        Production scale:

                        large

                        Strong heritage in pharmaceutical innovation and biotechnology.

                        Comprehensive range of services from early development to commercial supply.

                        Focus on quality, reliability, and sustainability in biopharmaceutical manufacturing.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                        • gmp

                        Replies slower than most

                        Located in:

                        United States

                        Plants in:

                        United States

                        Established in: 1933

                        Production scale:

                        large

                        Pioneering in advanced delivery technologies and development solutions.

                        Extensive global network ensuring supply chain resilience.

                        Tailored services across biologics, gene therapies, and pharmaceuticals.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                        • gmp

                        Replies slower than most

                        Located in:

                        China

                        Plants in:

                        China

                        Established in: 2023

                        Production scale:

                        medium

                        Employees: 34

                        Ensures stability across batches from gene editing to enzyme and UDCA production

                        GMP standards compliance to ensure the lowest levels of single, total, and C impurities within the product category

                        Customized services, supplying enzymes for UDCA conversion and crude UDCA products with purity from 85% to 99.99%

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                        • gmp

                        Replies quickly

                        Located in:

                        United States

                        Plants in:

                        United States

                        Production scale:

                        large

                        Leading in aerosol and transdermal drug delivery systems.

                        Expertise in both small molecule and biologic drug formulation.

                        Strong track record in bringing complex therapies to market.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                        • gmp

                        Replies slower than most

                        Located in:

                        United States

                        Plants in:

                        United States

                        Established in: 1996

                        Production scale:

                        large

                        small

                        medium

                        Leading in biopharmaceutical development and biologic API production.

                        Comprehensive services from cell line development to commercial manufacturing.

                        Strong track record in delivering complex and high-quality biologics.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                        • gmp

                        • ema

                        • fda

                        Replies quickly

                        Located in:

                        Italy

                        Plants in:

                        Italy

                        Dedicated to high-quality ophthalmic and ENT product manufacturing.

                        Emphasis on natural and gentle formulations for sensitive applications.

                        Italian excellence in innovative product development and production.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                          Replies slower than most

                          Located in:

                          United States

                          Plants in:

                          United States

                          Production scale:

                          large

                          Expertise in cell therapy development and manufacturing.

                          Tailored solutions for autologous and allogeneic cell therapies.

                          Cutting-edge technology for scalable and efficient cell therapy production.

                          • GMP

                          • FDA

                          • EMA

                          All certificates

                          • gmp

                          Replies slower than most

                          Located in:

                          Norway

                          Plants in:

                          Norway

                          Established in: 2007

                          Production scale:

                          small

                          large

                          Specialized in liquid and semi-solid pharmaceuticals manufacturing.

                          Nordic excellence in quality and reliability.

                          Flexible production capabilities catering to a wide range of batch sizes.

                          • GMP

                          • FDA

                          • EMA

                          All certificates

                          • gmp

                          Replies slower than most

                          Located in:

                          Canada

                          Plants in:

                          Canada

                          Established in: 2014

                          Specialized in sterile ophthalmic and injectable formulations.

                          Focus on flexibility and customization for client-specific needs.

                          Advanced manufacturing capabilities in a controlled environment.

                          • GMP

                          • FDA

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                          All certificates

                          • gmp

                          Replies slower than most

                          Located in:

                          United Kingdom

                          Plants in:

                          United Kingdom

                          Specialized in sterile and non-sterile pharmaceutical manufacturing.

                          Focus on flexibility and customization for client-specific needs.

                          State-of-the-art technology ensuring quality and efficiency.

                          • GMP

                          • FDA

                          • EMA

                          All certificates

                            Replies slower than most

                            Plants in:

                            United States

                            Established in: 2018

                            Production scale:

                            large

                            Successfully inspected by TGA, PMDA, MHRA, ANVISA, Health Canada, MPA, IMB, & FDA

                            All facilities are in good standing with all regulatory authorities, including DEA, EPA, OSHA

                            Quality Management System and supporting analytical processes are almost 100% electronic

                            • GMP

                            • FDA

                            • EMA

                            All certificates

                            • gmp

                            Replies quickly

                            Located in:

                            United States

                            Plants in:

                            United States

                            Established in: 1928

                            Production scale:

                            large

                            Advanced polymers technology for optimized drug delivery systems.

                            Global capabilities in complex formulations and specialty chemicals.

                            Emphasis on collaborative partnerships for innovative solutions.

                            • GMP

                            • FDA

                            • EMA

                            All certificates

                            • gmp

                            Replies slower than most

                            Located in:

                            United States

                            Plants in:

                            United States

                            Established in: 1995

                            Innovator in blow-fill-seal technology for sterile liquid dosages.

                            Expertise in unit dose packaging for ophthalmics and respiratory solutions.

                            State-of-the-art facilities ensuring precision and scalability.

                            • GMP

                            • FDA

                            • EMA

                            All certificates

                              Replies slower than most

                              Located in:

                              Belgium

                              Plants in:

                              Belgium

                              Established in: 2018

                              Production scale:

                              large

                              Comprehensive drug development services from molecule to market.

                              Expertise in nanomedicine and drug repurposing.

                              Tailored project management ensuring efficiency and transparency.

                              • GMP

                              • FDA

                              • EMA

                              All certificates

                              • gmp

                              Replies slower than most

                              What is a CDMO, CMO, and CRO?

                              Outsourcing terms are often used interchangeably, but they describe different scopes. This page is a directory for CDMO services and CMO services, with guidance to help you route correctly.

                              CDMO

                              Development + manufacturing: process development, scale-up, tech transfer, validation, and GMP production.

                              CMO

                              Manufacturing execution: GMP manufacturing, packaging, and supply continuity once the process is established.

                              CRO

                              Research and clinical support: analytical/bioanalytical work, clinical services, and research-heavy deliverables.

                              Practical rule: ignore the label and validate the scope (what’s in-house, what’s routine for them, and what they can support at your stage).

                              How to choose the right outsourcing model

                              Browsing suppliers is the easy part. Choosing the right outsourcing setup is where projects win or stall. Use the sections below to route correctly and approach suppliers with clear requirements.

                              Decision tree: where should you start?

                              This is a practical routing checklist (not a textbook). Use it to avoid contacting the wrong type of supplier.

                              1. What are you outsourcing?
                                Active ingredient / API / upstream manufacturing → start with Drug Substance (CDMO/CRO)
                                Finished dosage form / fill-finish / packaging → start with Drug Product (CMO)

                              2. Do you need development or only manufacturing?
                                Development + manufacturing → shortlist CDMO services
                                Manufacturing only (process already defined) → shortlist CMO services

                              3. Any specialized constraints?
                                Sterile manufacturing, high potency/containment (OEB), cold chain, controlled substances → shortlist specialized facilities first

                              4. Which stage are you in?
                                Early development / clinical → flexibility, small batches, fast iteration
                                Commercial → capacity, quality maturity, supply reliability, documentation readiness

                              How outsourcing typically works

                              A smooth outsourcing project is mostly about clarity and preparation. These steps help you move faster and reduce rework.

                              1. Define requirements (product type, stage, markets, batch sizes, timelines)

                              2. Build a shortlist (capability fit + region + quality requirements)

                              3. Share a concise project brief (and sign an NDA if needed)

                              4. Feasibility & proposal (timeline, costs, risks, required inputs)

                              5. Quality assessment (documentation review, audit readiness)

                              6. Agreement setup (quality agreement, responsibilities, change control)

                              7. Tech transfer (process, analytics, materials, packaging components)

                              8. Validation & routine supply (as required by stage and markets)

                              Supplier evaluation checklist

                              Suppliers respond faster and more accurately when your brief is clear. Use this checklist before outreach.

                              What to prepare before contacting suppliers

                              • Product type (Drug Substance / Drug Product) and dosage form (if applicable)
                              • Development stage (preclinical / clinical / commercial)
                              • Batch sizes and annual demand estimate
                              • Target markets (EU/US/other) and quality expectations (GMP, documentation)
                              • Key constraints (sterile, containment/OEB, cold chain, controlled substances)
                              • Timeline (tech transfer, first batch, launch window)

                              Questions to ask during evaluation

                              • Capability & experience: similar products? similar scales? which steps are in-house?
                              • Quality & compliance: inspections/markets supported, CAPA/change control maturity
                              • Capacity & timelines: realistic lead times, bottlenecks, mitigation plan
                              • Communication: ownership, cadence, escalation, documentation standards
                              RFQ template: what to include in your first message

                              If your first message is vague, quotes will be vague. Include the items below to speed up proposals.

                              • Scope: Drug Substance or Drug Product; development needed or manufacturing only
                              • Stage: clinical vs commercial; target markets (FDA/EMA/others)
                              • Volumes: batch sizes + annual demand estimate
                              • Constraints: sterile, containment/OEB, cold chain, controlled substances
                              • Timeline: desired start date, first batch, launch window
                              • Quality: required certifications, audit expectations, documentation level

                              FAQ: CDMO & CMO outsourcing

                              Quick answers for common sourcing questions. If you’re unsure, use the open inquiry option above and include your constraints.

                              Should I choose a CDMO or a CMO?

                              Choose a CDMO when you need development work (process development, scale-up, tech transfer support) along with manufacturing. Choose a CMO when your process is established and you mainly need manufacturing execution and supply.

                              What is the difference between Drug Substance and Drug Product?

                              Drug Substance is the active ingredient (API). Drug Product is the finished dosage form patients use (tablets, capsules, injectables, sprays, creams, etc.).

                              When should I involve a CRO?

                              Involve a CRO when your scope includes research-heavy work (bioanalysis, clinical services, specialized analytical tasks). Some CDMOs also provide CRO-like services; validate what’s truly in-house.

                              Can one supplier handle both Drug Substance and Drug Product?

                              Sometimes yes, but many suppliers specialize. The fastest approach is usually to shortlist based on the exact stage and manufacturing scope you need now, then expand if you want a single long-term partner.

                              How do I shortlist suppliers quickly without missing a good option?

                              Start with scope (Drug Substance vs Drug Product), then filter by constraints (sterile, containment/OEB), target markets (FDA/EMA), and scale (batch size). Only then compare “nice-to-haves.”

                              What affects price the most in outsourcing quotes?

                              The biggest drivers are development effort, complexity (sterile/containment), batch size, analytical requirements, validation scope, and documentation/market requirements. Clear inputs reduce pricing uncertainty.

                              Do I need an NDA before contacting a CDMO/CMO?

                              Often yes if you need to share sensitive details. Many suppliers can review a high-level brief without an NDA, then sign one before detailed transfer.

                              How do I verify GMP capabilities?

                              Check relevant certifications/inspections for your target markets, ask what’s in-scope at the specific facility, and validate quality systems (deviations/CAPA, change control, batch record/release workflow). Audits are common for final confirmation.

                              How long does it take to onboard a new outsourcing partner?

                              It depends on stage and complexity. Expect time for feasibility, quality assessment, agreements, and tech transfer. Sterile, high potency, or complex biologics typically require longer lead times.

                              What should I include in an open inquiry to get better matches?

                              Include product type (Drug Substance/Drug Product), stage, markets, batch sizes, key constraints (sterile/OEB/cold chain), and timeline. The more specific you are, the fewer irrelevant matches you get.