Regulatory Affairs

Regulatory Affairs

How it works

As a Regulatory Affairs consultant expert assist clients with regulatory aspects related to clinical studies submissions (Phase I-IV, observational) and MAA (Medicinal Products, Veterinary medicinal Products, OTCs, Generics, Nutraceuticals, Medical Devices, Cosmetics, Products for self-care, Biocides, Biologics, ATMP, Biosimilar products authorization processes), Herbal Products, Homeopathic Products.

Provide regulatory support and strategy to follow (Roadmaps) to get the Regulatory Approval in compliance with local and international regulations and guidelines.

Regulatory Activities

  • Regulatory Support and strategy to follow (Roadmaps)
  • Review completeness and accuracy of regulatory documents
  • Prepare submission package
  • Management of electronic submissions according to applicable requirements
  • Ensure final regulatory authorization are granted Manage

Regulatory Procedures

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