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A female scientist wearing a lab coat is manipulating some glass tubes close to an HPLC system

Collaborating with you to advance molecules into drug products

Our CMC services help you navigate all aspects of pharmaceutical development: 
  • Process: development and scale-up
  • Analytics: large and small molecules
  • Formulation of liquid and semi-solid
  • Clinical trial supply  
  • EU-QP release 
  • Troubleshooting (e.g., impurities, ICH M7 assessment, nitrosamines, solid form studies)
  • Integrated dermatology solutions.

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Simplify your CMC journey today

Your proactive, dedicated partner from drug substance to commercial drug product and beyond. We offer flexibility and a willingness to adapt to your needs, for a strong, trusted and long-term relationship.
  • 3 locations providing integrated GxP value-chain solutions in Germany and France, from early development to commercial 
  • >200 team members: industry-experienced scientists, pharmacists and lab professionals enhancing efficiency, compliance and data quality to safely and effectively support your products to the market
  • 40 years in the industry serving small biotech to big pharma organisations and projects
  • State-of-the-art technology and the capability to provide a unique combination of technologies and know-how
  • Strong project management – providing a solution-oriented mindset. 

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Every project is unique, so why settle for a one-size-fits-all approach? We tailor our services according to your needs:

Scientist wearing gloves assembling molecular structure with glass atoms in a laboratory setting
  • Route scouting
  • Process development
  • API manufacturing under GMP
  • Tox & GMP batch manufacturing 0.1 kg up to 10 kg
  • HPAPI up to OEL 0.1 µg/m3.

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Two hands in gloves doing cream formulation
  • Formulation strategy
  • Target product profile
  • Pre-formulation
  • Formulation screening & development
  • IVPT & IVRT for topicals
  • Formulation selection
  • Highly potent API.

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Clinical Samples being processed by the bioanalytical laboratory for PK, PD, biomarkers 
  • Small and large molecules
  • Method development, validation & transfer
  • QC testing of DS and DP
  • CCIT and functional tests
  • Stability studies [in-use, ICH]
  • Forced stress & photostability
  • Highly potent API.

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Investigational Medicinal Product prepared for a Clinical Trial 
  • Manufacturing
  • Primary & secondary packaging
  • Clinical labelling activities
  • IMP import & export
  • Comparator sourcing
  • Global distribution incl. depot management
  • Highly potent API.

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Glass jar spilling assorted pills with a paragraph symbol, representing pharmaceutical law and regulations
  • Worldwide auditing of supply chain sites
  • Regulatory support for IMP importation
  • QC release & CoA
  • Final EU QP release for IMPs
  • Final EU QP certification for commercial batches.

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