Pre-Clinical - Safety & Efficacy Trials
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies is your leading partner for specialized preclinical services for a complete IND/IMPD package that includes Safety Assessment/Toxicology and Drug Metabolism and Pharmacokinetic (DMPK) studies along with Chemistry, Manufacturing and Controls (CMC) services.
With more than 25 years of compliance, our GLP and AAALAC accredited laboratories operate under OECD and ICH guidelines for regulatory Safety Assessment studies to ensure global regulatory compliance, along with cGMP compliance for material generation for preclinical & early clinical development. Over the years, we have helped companies with over 50 IND filings worlwide with regulatory agencies such as USFDA, MHRA, EMA, TGA and Health Canada.
Choose Eurofins CDMO network of companies to help you:
? Perform the full range of safety assessment/toxicology studies required for all phases of nonclinical development.
? Access an unparalleled combination of experience and laboratory resources, spread globally throughout the US, Europe and India.
? Get your drug candidate approved by global regulatory agencies.
? Partner with a one-stop end-to-end solution for all your IND, CMC and nonclinical development requirements.
Pre-Clinical - Safety & Efficacy Trials | ||
ADME/DMPK |
Genotoxicity Studies |
Safety Pharmacology |
Safety Assessment/Toxicology |
Bioanalytical Support (Small & Large Molecule) |
|