Medicinal product registration See the offer
Dossier compilation and publishing See the offer
Medical Writing See the offer
Medical Devices and IVDs See the offer
Provision of marketing authorization services See the offer

We offer:
0. Medicinal product registration
  • Dossier submission according to national, mutual recognition, decentralized and centralized procedures
  • Preliminary assessment of the documents
  • Report preparation on the dossier readiness for the submission
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0. Dossier compilation and publishing
  • Full dossier review and eCTD publishing services
  • Assessment of old dossiers - document analysis and its update to be ready for submission
  • Preparing the Dossiers in eCTD for initial submissions/renewals/variations
  • Life cycle management of the product(s)
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0. Medical Writing
  • Summaries of product characteristics (SPCs) and Package leaflets (PL)
  • Readability User Testing Reports or Bridging Reports
  • Risk management plan
  • Environmental Risk Assessments
  • Quality Overall Summary
  • Clinical and non-clinical overview and Summary
  • Module 4 and Module 5
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0. Medical Devices and IVDs
  • Clinical Evaluation of Medical Devices
  • CE Marking Consulting for Medical Devices and IVDs
  • Guidance on medical device classification
  • Consulting on the European Medical Devices Directives
  • Technical File Preparation for Medical Devices and IVDs
  • Interaction with and documentation preparation for Competent Authorities
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0. Provision of marketing authorization services
  • Complete MAH services (including MAH transfer)
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0. Additional services
  • On request
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