Our regulatory team has a thorough understanding of the regulatory requirements of the regulated and semi regulated markets. The regulatory expertise encompasses the following areas:-
• Dossier development and regulatory strategy for EU CTD, ACTD, MCC and JFDA.
• Updating of scientific references with apt technical knowledge backing with a respect to the IPR.
• Deficiency review and response management.
• Technical document management according to cGMP norms.
• Labelling and promotional literature review