- Named Patient Programs while available in the Territory, only allow limited access. An approved product by Roszdravnadzor is important
- Regulatory Affairs occupy a central role in securing early products’ entry to market. Our team ensures compliance with regulations across different markets and enables understanding and interpretation of the dynamic regulatory landscape through:
- Established knowledge of local regulations ensuring
- Submitted files are compliant with the requirements
- Approvals are within set timelines at convenient price
- Strategy development and planning of the marketing authorization dossiers
- Effective monitoring of variations and renewals ensuring continuous product supply to markets
- Optimization of submission strategies permitting:
- On time registration and reimbursement of our products
- Successful inspections and audits
