Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.
Photosafety EvaluationTherapeutic Area-SpecificImmunotoxicology StudyToxicokinetics and PharmacokineticsSafety Pharmacology StudyBiotechnological ProductReproductive ToxicologyRepeat-Dose ToxicityNonclinical Safety in Paediatric MedicineCarcinogenicity StudyGenotoxicity Study
This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.View this resource Bookmark this resource