"For the professional calling"
Regulatory activities
Our company's activities include the support of other activities affecting the products of pharmaceutical manufacturers and distributors, in the following areas.
Our company’s activities include the support of other activities affecting the products of
pharmaceutical manufacturers and distributors, in the following areas.
Marketing Authorisation (MA)
- National Procedure
- Mutual Recognition Procedure (MRP)
- MA Variation
- Readability Testing
- Braille Script Testing
- Renewal
- Withdrawal
- Permission for Alteration from MA
- Switch to Medical Product Category
- Extention of Expire Date of Batches
- Reporting
- Follow up
- Report gatering
- PSUR back up
- Literature follow up
- Announcement (non prescription)
- Monitoring
- Reimbursement Application
- Price Change Announcement (reimbursed)
Become our partner!
In case of need of further information please appeal with confidence to one of our colleagues: office@renewkft.hu