Development SubstipharmExpertiseDevelopment Our experienced R&D team handles all development steps from early stage formulation to manufacturing process validation. Our field of application is wide: generics, prescription brands, OTC, food supplements, of any kind of administration forms. We are duly aware of development dynamics and thus are committed to timelines adherence. SUBSTIPHARM’s R&D department collaborates with partners and scientific experts all around the world (EU universities, international CDMOs and CROs, …). Below are the main missions of our R&D team: Regulatory Affairs Our Regulatory Affairs Team provides our Partners with a full and comprehensive regulatory support, during all phases of the product life-cycle. Their great demand level in dossiers redaction and their expertise in Regulatory strategy design allow us to achieve quickly and successfully any registration procedure we start. Their tasks comprise: Pre-submission activities Marketing Authorization Applications through CP/DCP/MRP/NP Post-Marketing Authorization Maintenance FDA Filing Expertise Dietary supplement OTC Generic medicines Niche products MAA files Complex galenic forms Any questions? Want more information about our services, our expertise or how to work with us? CONTACT US Company About us History Thinking Careers Expertise Development Supply Contact us! 24 rue Erlanger - 75016 Paris - FRANCE +33 (0)1 43 18 13 00 © Copyright Substipharm 2019 Legal Notice Cookies management Sitemap Website by SWAT If you continue to browse this website, you are allowing all third-party services ✓ OK, accept all Personalize