Impurity Safety Assessment (ICH Q3A, ICH Q3B and ICH M7), Genotoxicity, Toxicity and Risk Assessment.Environmental Risk Assessment (ERA) for Medicinal Products for human use,as for EMEA/CHMP/SWP/4447/00.Permitted Daily Exposure (PDE): Assessment for Medicinal Products/Active Ingredients in shared facilities (EMA/CHMP/SWP/169430/2012/00).Preparation and Medical/Scientific Review of advertising materials.Scientific Support to production of promotional material.Clinical study protocol and report preparation: Phase I, Phase II, Phase III, and Phase IV studies, including bioequivalence and PK/PD studies.Drafting a BCS based biowaiver or drafting justification document /scientific rationales to support regulatory queries.Reformatting of old application dossier to NeeS/e-CTD.Module 1: SmPC (CCDS – Company Core Data Sheet) and RMP Region-specific, PL and labelling.Module 4 and Module 5 – Pre-clinical and clinical study reports.Module 2.7 – 2.6 Clinical and pre-clinical summaries.Module 2.5 – 2.4 Clinical and pre-clinical overviews.Clinical and Non-Clinical sections of the Common Technical Document (CTD) for EU, US and ROW Regulatory Authorities (Modules 2.4, 2.5, 2.6, 2.7, 4 and 5), following ICH M4 guideline and Volume 2 B guidelines- Presentation and format of the CTD.Product Development BU PLG offer support and resources for the following services:
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