ICPC BIZ

1000+ DMF, AMVs, Dossiers, COAs available 100+ clients services around the world 20+ manufacturing sites The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorization or registration for a medicinal product. Dossiers are at the forefront of this process. ICPC BIZ Regulatory Team works on behalf of pharmaceutical companies to compile information about medicinal products and present it in the form the authorities require. Clients have been placing their trust in ICPC BIZ expertise in preparing and maintaining such dossiers. ICPC BIZ compiles all information on clinical studies, medical safety and efficacy trials, medicinal product quality, analytical testing, approved use, pharmacovigilance and much more in an (electronic) common technical document, eCTD dossier. ICPC BIZ carries out the maintenance of marketing authorization documents with the correct combination of accuracy and efficiency. Regulatory affairs specialists provide advice ICPC BIZ takes over every aspect of maintaining and (re)formatting of existing documentation in eCTD or CTD format as needed. Apart from its vast experience in Regulatory ICPC BIZ unlocks its network to clients and connects you to state of the art pharmaceutical FDFs, API & excipient manufacturers worldwide. TABLETS, CAPSULES, LIQUID, INJECTABLES, SURGICALS, FOOD SUPPLEMENT ICPCBIZ services include: • Marketing authorization dossiers for human medicinal products (CTD modules 1 to 5) • Marketing authorization dossiers for veterinary medicinal products • Planning, preparing, updating and reformatting of quality dossiers • Compilation of pharmacological/toxicological expert reports, clinical expert reports, environmental compatibility testing, etc. • Communication with regulatory authorities • Monitoring of deadlines • Variations & Renewals • Reformatting CTD > eCTD • Supplying DMF, Drug master files, AMV Analytical Method Validation • Pharmaceutical technology Transfer