The Drug Products Category we operate with:
505 (b)(2) and 505(j) application with USFDA, Article 10 (1) submission in EU and national submission with independent agency.
EU GMP for veterinary medicines and product dossier filing with MAH in EU.
Super generics development support and approval.
EU & Emerging markets submission and approval support.
BLA submission via 351(k) pathway, Article 10(4) application with EU, BRICS-TM regulatory intelligence and submission.
EU and Emerging markets regulatory intelligence and submission support.