Regulatory affairs

1. PREPARATION/SUBMISSION OF MARKETING AUTHORIZATION APPLICATIONS

  • National registration.
  • MRP/DCP/CP registration.
  • Human medicinal products (MPs, DCP, MRP, NP).
  • Veterinary medicinal products (VMPs, DCP, MRP, NP).
  • Medical devices.

2. SPECIAL MEDICINES AREAS

  • Innovative and generic medicinal products (including biotech),
  • herbal medicinal products (natural medicines),
  • strong vitamin and mineral products,
  • medicinal gasses,
  • radiopharmaceuticals,
  • food supplements,
  • cosmetics,
  • biocides,
  • vaccines,
  • homeopathic medicinal products,
  • blood products and plasma-derived medicinal products.

3. EXPERT REPORTS – PRE-AUTHORIZATION – POST-APPROVAL AND SUBMISSION SUPPORT

  • various applications, renewals, and notifications,
  • update and upgrade of documentation,
  • SPC, PIL, labelling in accordance with national legislation,
  • marketing materials review, harmonization with approved medicinal products documents,
  • communication with authorities (new requirements/answers to deficiency/ clarifications/permissions),
  • packaging materials (mock-ups/artworks) and proofreading.

4. PHARMACOVIGILANCE

5. TRANSLATION