Regulatory

Services

Clinical Operations
Regulatory
Project Management
Medical Writing
Data Management

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