Regulatory Affairs
- Competent team to undertake complete requirements for the customer’s geography.
- Submissions of eCTD for EU, ANDA’s 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.