Pharmaceuticals

Providing Non-Clinical Drug Safety Expertise

For our clients from the pharmaceutical industry, we provide the following type of non-clinical services:

Non-clinical Testing Programme
Strategic nonclinical programme design with study plan, placement, monitoring and review.

CTD Dossiers
Nonclinical eCTD dossier preparation in support of marketing applications and variations within Europe, United States and Japan.

Representation
Expert representation on non-clinical part of the registration dossier to regulatory authorities.

Post-marketing support
Client support to post-marketing surveillance programmes including adverse reactions, PSUR’s, product specification changes.