Regulatory

Regulatory lies at the very core of our professional services offering.

Over the last five years we have completed over 100 new registrations in Russia alone; more than any other agency. Many of these products were orphan or originals, testifying to our capability even in the most complex regulatory affairs. Our commitment to quality, deep knowledge of all local regulations and professional dedication enable us to complete registrations in record time, effectively organizing the entire process including the local pre-clinical and clinical studies required for drug registration.

Our regulatory team is second-to-none. Raifarm professionals bring excellent experience from past employment with regulatory bodies and/or international pharmaceutical companies. Additional training at Raifarm, along with wide exposure to various registration assignments, helps further develop their skills.

Our regulatory services include:

  • Registration of new medicines and medical devices
  • Completion of pending regulatory submissions
  • Renewal of registrations
  • Approval of various registration changes (for example new dosage, new indication, new routes of administration)
  • Post-approval regulatory and pharmacovigilance support