R.b. Singh Panwar
Agroservis - Limited liability company
• Preparation and review of the dossiers as per the current prescribed guidelines of the US FDA • Ensure documentation complies with eCTD & CTD regulations for US(for all ANDA,IND and NDA) • Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, Batch records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier. • Review of documents required for regulatory agencies (Viz. Analytical reports, Process Validation Report, Process Validation Protocol, Master Formula Record, Batch Manufacturing Record, Pharmaceutical Development Reports, Protocol & Stability Data). • Preparation / Review of labelling & Package material, packing insert the finish formulation marketing materials, Promotion materials under supervision. • Preparation and review of Package insert and Labeling information.
total documentation system.