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Experts in Business and Management
Gerhard J. Barone Dr. Hanumant Yadav Jack Jonck DOÄžANAY, Mehmet Mete Bernardo Balboni G. Eddy Birrer Cem Behar Bin Ke Cengiz Kallek Michael Frese Engin Akarli Andrew M. Brajcich Robert Lee Ensar Gul Irene Elisabeth De Pater RUOLIAN FANG REMUS ILIES Geraldo Cerqueiro Timothy G. Coville Ghee Soon Lim View MoreR.B. Singh Panwar
dermaceutical
Agroservis - Limited liability company
Argentina
• 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.