Regpace Regulatory Solutions is rated 3 out of 5 in the category international affairs. Read and write reviews about Regpace Regulatory Solutions. We, at Regpace are equipped with the latest regulatory expertise needed for the smooth operations for your Regulatory Department. The key expertise’s are as follows: 1. Drug Dossier Compilation (CTD, eCTD, aCTD, Module I-V, DMF Part, Clinical Part viz. Bio equivalence & Clinical Trials) 2. Medical Device Dossier Compilation (CE Mark, QMS, ISO-13485, ISO-14971) 3. Pharmacovigilance services (Pharmacovigilance System, Pharmacovigilance System Master File, Periodic Safety update report - PSUR, Risk Management Plan) 4. CDSCO Liasoning for Product Registration, Shelf Life Extension, Test License, Export NOC in all division viz. New Drug / Import Division / Biological (Vaccine, Stem Cell, Blood Products, recombinant products) / Medical Devices / Diagnostic Kits / Blood Bank / Cosmetics / Narcotic Drug / Export & Neutral Codes / Test Licence / LVP Division. 5. Document attestation, legalization or apostille from Chamber of Commerce, Ministry of External Affairs, Embassy and Consulates. 6. Translation (Guidelines, Dossiers, Package Inserts, Artworks) 8. Designing (Artwork, logo, brochure, conference booth) Be in touch if any of these or any other regulatory puzzle has to be solved. Regpace is one stop solution for all your Regulatory related needs.
Address
Abul Fazal Phase I Main Road