Marketing Authorisation (MA)

  • Preparation and submission of dossiers for MA applications (National, Decentralised and Mutual Recognition Procedures).
  • Activities required for local compliance following Centralised Procedures.
  • Co-ordination of MA Applications to ensure timely approvals via intensive follow-up correspondence and effective collaboration with Health Authorities.
  • Consultancy services concerning local regulatory requirements.

Product Maintenance 

MA maintenance and constant product update according to requirements:

  • Variations
  • Renewals
  • Post-approval notifications
  • Sunset Clause
  • Local contact point

Regulatory & Medical Documents

  • Non-clinical and clinical literature overviews.
  • Regulatory review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling.
  • Translations of Product Information (SmPC, Labeling and PIL) to local language.
  • Regulatory review of packaging material.
  • Regulatory review of promotional material.

Pharmacovigilance

  • Provision of local Responsible Person for Pharmacovigilance.
  • 24/7 Pharmacovigilance service and coverage of urgent medical queries.
  • EudraVigilance and electronic submission of medicinal product reports via EVWEB.
  • Literature screening (Medical & Scientific literature search and Adverse Event identification ).
  • Educational Material local language translation, review and submission to Health Authorities.
  • Direct Healtcare Professional Communication; preparation and / or local language translation, review, submission to Health Authorities and circulation to local Healthcare Professionals.
  • Submission of safety reports.
  • Scientific and medical HCP communications / visits as partial fulfillment of local Medical Affairs or Medical Science Liaison (MSL) service.

Market Access

  • Pricing applications.
  • Sales Submissions.
  • Regulatory review of applicable Marketing Material.

Medical Devices

  • Local notifications or registrations of Medical Devices to local Health Authorities.
  • Support for preparing Technical File.
  • Act as local contact point to Health Authorities.

Contact us for any inquiries concerning our services or to discuss about specific requirements that we can be of assistance.