Regulatory Affairs
Bringing a new product from development to market 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 colleagues are ready to work with you to set and help deliver on aggressive timelines that control costs.
The regulatory expertise at AGINKO can benefit your project during all phases of development.
Clinical Trial Services
- Advice on regulatory procedures
- Preparation and submission of clinical trial applications (CTA)
- Local accompanying of the approval process and communication with regulatory authorities
- Provision of official documents, specific procedures and translations
- Drug importation for clinical trials incl. narcotics
- Submission of IDE; PMA; BLA, 510 (k); HDE; Pre-IDE/BLA, Panel Meetings
To read more about Preclinical and Clinical regulatory, Click Here
