Regulatory Affairs

Baggerman Farma Consult has been involved in the regulatory procedures for a wide variety of drugs and medical devices and is fully acquainted with the EU Directives involved. The company supports or advices on the regulatory processes including:

  • Marketing Authorization Applications (MAA)
  • Product Dossier Maintenance (preparation, submission, follow-up)
  • Regulatory procedures (Centralized, MRP/DCP, national)
  • Preparation and updating of SPC, Patient Leaflets, Labelling text
  • Due Diligence review of MA’s

The company is also involved in the CE marking procedures for various types of medical devices as well as safety evaluations of cosmetics.

Baggerman Farma Consult is familiar with the documentation required for the regulatory processes, including nonclinical, clinical and pharmaceutical overviews and technical files. Other areas of the company’s expertise are clinical trial applications and reimbursement procedures for pharmaceuticals as well as vigilance programs for drugs or medical devices.