Regulatory Affairs
Competent team to undertake complete requirements for the customerís geography.
Submissions of eCTD for EU, ANDAís for USA, or any other geographic filings. Work with specific, compatible database       tools.
Running (Centralized) procedures like Centralized/MRP/DCP (EU).
Active substance Master File review and actions closure.
Variation strategies to reduce cost and time; filings & queries management, with customer as front end.
Screening of in-licensing dossiers for registration success.
Managing maintenance, renewals etc.
Assist in technology transfers and new sourcing strategies.
Closely work with artwork development and pharmacovigilance to ensure regulatory compliances.
Close interaction with Formulation R&D projects for fast and successful authorisations.