The services we provide cover all the steps that must be taken to introduce a new drug, food supplement or medical device on the Romanian drug market.
- 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, switch to OTC and all other regulatory activities.