Getting your new products approved requires going through a challenging, expensive, and lengthy clinical development and submission process. Whether your new product is a drug or a biologic device, our team fulfils all regulatory requirements and has the resources and proven expertise to address your specific needs.
Regulatory Authority Applications & Approvals
- Initial Application, preparation for Ethics Committee and Ministry of Health
- Initial application file preparation for Regulatory approval
- Follow-up of applications
- File preparation on regulatory and administrative changes during the study
- Pharmacovigilance reporting to EC's and Regulatory Authority
- Applications to RA for site coordinators
- Institutional review board
- Negotiating and concluding contracts with study sites
- Submissions for public hospitals
- Applications to the Ministry of Health on behalf of Phase I study sites