We can support you, the sponsors, to ensure proper execution of the non-clinical study protocols and successful regulatory filing.
Directive 2001/83/EC, as amended, request the consideration of petential risks to the encironment arising from the use, storage and disposal of medicinal products, as well as potential precautionary and safety and safety measures to be taken and the preparation of an ERA report.
Study placement and monitoring
Preparation of non-clinical sections for Investigator Brochures
Preparation of CTD Dossiers for CTA/NDA (Modules 2 & 4)
Preparation of Permitted Daily Exposure (PDE) monographs for active pharmaceutical ingredients
Safety Qualification of impurities in drug substance/products