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3Z
REGULATORY AFFAIRS
Nowadays, Regulatory Affairs play a central role in the pharmaceutical business.
Regulatory knowledge and expertise are an integral part of modern development and marketing strategies for medicinal products.
We can offer you the following services:
  • Preparation, translation and adjustment of PIL, SmPC, mock-up (including Braille) to the requirements of the local Authority
  • Readability Testing of PIL: preparation, testing, translation and report submission
  • Variations procedures of any kind - preparation, submission and monitoring
  • Renewals of MA (marketing authorizations)
  • Obtaining of MA
  • Transfer of MA
  • e-Submission Management including reformatting from CTD to eCTD or NeeS
  • Advisory service on regulatory affairs
  • Application of medical devices to the Register of Medical Devices
  • Notification of food supplements and cosmetics
  • Local Pharmacovigilance services
  • Registration of Clinical Trials in CEBK (Central Evidence of Clinical Trials)
  • Application procedures (MRP, CP, national).