IMP Manufacturing and Development (CDMO)
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IMP Development and Manufacturing
State-of-the-art development and manufacturing outsourcing services for small molecule and biological entities
Eurofins CDMO helps bio-pharmaceutical companies move rapidly from research stage of their drug development to clinical stages with integrated services to compress timelines to market.
Eurofins CDMO delivers comprehensive solutions to streamline the development and manufacturing of a variety of product types, delivery systems and dosage forms (oral, topical, nasal and parenteral):
- Pre-clinical safety assessment
- Formulation screening and development
- Analytical Development, stability studies
- Non-GMP & GMP manufacturing services (Non Sterile and Sterile)
- Clinical trial supply
- IND/ IMPD and NDA/ CTD services
- End-to-end development & manufacturing solutions for both Drug Substance / API and Drug Product for Biologicals and Small Molecules.
End-to-end development & manufacturing solutions for both Drug Substance / API and Drug Product for Biologicals and Small Molecules.
Small Molecules Development & Manufacturing
- Drug Substance (DS) /API Development & Manufacturing including Highly potent/Cytotoxics
- Solid State Research & Development
- Pre-Formulation/Formulation
- Drug Product (DP) Development including Highly potent/Cytotoxics
- Sterile Manufacturing (Liquids, Powders) including lyophilisation
- Non-Sterile Manufacturing (Liquids, semi-solids, solids)
Biologics Development & Manufacturing
- Cell Banks/Drug Substance
- Pre-Formulation/Formulation
- Drug Product (DP) Development and including Highly potent/Cytotoxics
- Sterile Manufacturing (Liquids, Powders) including lyophilisation
- Non-Sterile Manufacturing (Liquids, semi-solids, solids)
Clinical Trial Material (Packaging & Logistics)
- Primary Packaging
- Secondary Packaging & Labeling
- QP Services
- GMP Storage & Distribution including Direct-To-Patient services
Regulatory Services
- IND/IMPD
- NDA/CTD
