Regulatory Affairs
Bringing a new product from development to marketing approval is an expensive and lengthy process. If unanticipated delays occur, costs in both time and money can rapidly escalate.
Whether your new product is a drug, a biologic, a device or a combination, our experienced people are ready to work with you to set and help deliver on aggressive timelines that control costs.
The regulatory expertise at Scope International can benefit your project during all phases of development.
The services we offer:
- Advice on regulatory procedures in Central and Eastern-European countries
- Preparation and submission of clinical trial applications
- Local accompanying of the approval process and communication with regulatory authorities
- Provision of official documents, specific procedures and translations
- Drug importation for clinical trials