Services

Marketing authorisation applications

  • Planning of marketing authorisation strategy
  • Preparation and management of applications
  • Evaluation of marketing authorisation dossiers
  • Coordination of MRP, DCP, NP and CP processes
  • Acting as applicant and Marketing Authorisation Holder

Maintenance of marketing authorisations

  • Variations
  • Notifications
  • Renewals
  • Rx to OTC switches
  • MAH transfers

eSubmission

  • Compilation of eCTD, NeeS and VNeeS
  • Submission by CESP

Product information texts (SmPC, PL, labelling)

  • Writing
  • Translations
  • Package leaflet user tests and bridging reports
  • Proof-reading of mock-ups
  • Updating of local compendia texts

Review of promotional material

  • Medical review
  • Editorial review

Additional services

  • Strategic regulatory planning
  • Project management
  • Consultation regarding e.g. product classifications, scientific advice, national requirements
  • Training

regulanet® network covering more than 90 countries

  • Local marketing authorisation, pharmacovigilance and market access related tasks
  • Consultation concerning local regulations, practices and authorities’ opinions