Regulatory Affairs

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Pre-launch activities

  • Global Regulatory Strategies
  • Evaluation of documents in view of current US/European rules and guidelines
  • Pre-meeting packages preparation, INDs/CTAs and post-filing submissions, BLA/NDA/NDS/MAA filings
  • Writing of individual documents of the CTD-modules 2-5
  • Dossier compilation (paper-based or electronically – eCTD) and partial or entire management of the registration process
  • Scientific and medical writing services

Post-launch activities:

  • Adherence of regulatory compliance / maintenance
  • Dossier reformatting (CTD to eCTD)
  • Management of Pharmacovigilance activities
  • Renewal of marketing authorisation
  • CMC and Labelling variations management
  • Market access and Line extensions
Pharmacovigilance