Our corporate mission is focused on rregulatory and clinical trial affairs in Bulgaria.
Betaconsult Pharma Ltd., with its expert team with more than 20 years experience, will provide a comprehensive strategy to help you meet your regulatory and business obligations and will assist you as a local regulatory contact in Bulgaria;
Betaconsult Pharma Ltd. provides online legislative information (ongoing and future) to local regulatory affairs requirements for clinical research, drug regulatory affairs including pharmacovigilance and intellectual property.
1. Regulatory Affairs
- Advice on local requirements for each type of applications as well as MRP, DP, National Procedure.
- Evaluation, advice and submition of applications to the national regulatory authority.
- Review CMS documentation for due diligence and gap analysis
- Life Cycle Management Services: Variations and renewals to keep your products up-to-date., variations, renewals, provision of regular status updates on project progress in Bulgaria,
- Review of product packaging /labelling and advice on required changes.
- Proof reading and local regulatory approval of artwork.
2. Health technology assessment in Bulgaria according to the local requirements - pricing and reimbursement based on the local legislation;
3. Outcome research according to the Positive Drug List legislation in Bulgaria;
4. Clinical trial applications, amendments and closure of the procedure with the local authority and with the Ethic Committees;