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