Titenare Gxl Technologies Private Limited

Become the proven, trusted and value-added one stop solution provider to the Pharmaceutical, Food, Healthcare, Personal Care, Device and Electronic Industries.

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.