REGISTRATION OF MEDICINES, FOOD SUPPLEMENTS, MEDICAL DEVICES
- Consultancy on Romanian regulatory environment and strategies related to medicines, food supplements, medical devices, including comprehensive regulatory intelligence.
- Preparation of documents in compliance with the requirements of local regulations for registration of new products / renewal procedure.
- Submission of the application to competent authority, correspondence and follow-up with the authorities during procedure.
- Post-approval regulatory activities: transfer of Marketing Authorization, approval of packaging according to local and EU regulations, submission of variations and line extensions, renewals, submission of promotional materials and all other regulatory activities.
- Pricing – preparation, submission of the files and obtaining official price order.
- Reimbursement – consultancy and submission of reimbursement applications.