Regulatory Strategy

  • METINA can help defining regulatory strategy to identify & mitigate potential challenges at early stage of development so as to obtain speedy approval for EU, USA and Emerging Markets
  • Defining Clinical (CT/BABE, Published information, RLD/Comparator suggestion), Non-clinical (pre-clinical/Tox data) and Technical requirements (API and Drug Product specification & advise, Stability data, evaluation and proposed shelf life,) and support to develop quality product dossier
  • METINA helps clients preparing Country Specific Product Strategy at the time of Product development
  • METINA can develop strategies for Clinical Trial Application in India, Brazil, Russia, Bangladesh, Philippines, and Malaysia)
  • Existing dossier suitability to new market (Gap analysis and solution)
  • Defining critical regulatory information and strategic plans for drug development based on prevailing Regulatory Guidelines, analyzing fast track approval possibility, specifying Regulatory Process, Timelines for approval and applicable fees, Relevant precedents based on earlier opinions/ queries
  • Defining risks/ regulatory barriers (i.e. WHO-GMP, COPP, Price Approval, Site Inspection, Approved BE Center, Co-validation at out of India,) and mitigation plan
  • METINA supports clients in preparing Global Submission strategy for a single product
  • METINA can help clients to scale up Non-CTD to CTD dossiers and from EU/US CTD to Regional CTD format
  • Regulatory framework and Roadmap for approval