Marketing authorisation and registration

Preparing documentation

  • Compiling the parts of module 1–5 for pharmaceuticals and the application
  • Compiling and maintaining of eCTD-dossier
  • Technical file for medical devices, clinical evaluation, risk analysis, reviews
  • Product safety assessments for cosmetic products
  • Self-monitoring plan for nutritional supplements
  • Preparing the documents required for use abroad in accordance with the local requirements

Handling regulatory processes

  • Marketing authorisation, renewal and change applications for pharmaceuticals
  • Acting as a contact person
  • Launch and certification of medical devices

Labelling, package leaflets and summary of product characteristics

  • Planning and preparing product informations
  • Proofing
  • Translations
  • Handling print runs (mock ups)

We also have the capabilities to act as the holder of marketing authorisation for our customers’ products.