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
Click to order
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)
Click to order
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
Click to order
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
Click to order
0.
Provision of marketing authorization services
- Complete MAH services (including MAH transfer)
Click to order
