Medicines – Regulatory Affairs

  • Assisting in formulating regulatory strategies
  • Maintaining communication with Regulatory Authorities on behalf of clients
  • Handling the preparation and submission of marketing authorization applications across various procedures (National, Mutual Recognition, Decentralized, and Centralized)
  • Managing marketing authorization variations, including type-I, type-II, extensions, and safety-related changes
  • Facilitating marketing authorization renewals
  • Conducting readability tests and preparing Bridging Reports
  • Reviewing and approving mock-ups/artworks
  • Managing Exceptional Use Authorization applications
  • Handling parallel imports application procedures
  • Preparing and submitting applications for clinical trials (CEIC and INFARMED)
  • Compiling Experimental Medicine dossiers