Regulatory support

Regulatory support in the course of a clinical study ensures that investigational medicinal product / medical device would be developed and then marketed in accordance with applicable legislative requirements. Synergy provides its clients with continuous regulatory support comprising:

  • Current regulatory trends tracking and scientific advice
  • Preparation of a clinical trial dossier
  • Initial submission to regulatory authorities
  • Submission of protocol amendments
  • Import/Export Licenses
  • Preparation and submission of safety reports
  • Submission of a clinical study report
  • Interaction with Central and Local Ethics committees

Continuous support

Regulatory support is a continuous activity which step by step traces the entire medicine / medical device development process starting with the development of a drug concept and which culminates with often complex post-marketing activities. Synergy can provide a full range of regulatory services for clinical trials in Russia, the EAEU and CIS countries, as well as separate (individual) services at the client’s request.

Legislative compliance

The key objective of regulatory support is to ensure that all the interactions arising during the course of the drug development process, including clinical stage, are in compliance with applicable rules and regulations.

Local experience

Synergy is mostly operating in the countries of emerging clinical trials markets whose regulatory environment differs from the regulatory approaches of the ICH-countries. Actually, all the applicable national requirements in most countries are based on the ICH principles, but because of the local peculiarities the regulatory approval process varies from country to country and has its specific nuances and know-how. It is the thorough knowledge of the regional regulatory environment that is the key to a proper strategy for a clinical development program as well as for choice of an optimal clinical trial design.

In turn, emerging markets are creating unique opportunities for pharmaceutical and medical device companies to expand their international representation by means of locally conducted clinical studies, which allow attracting the required number of patients, and also facilitating the national marketing authorization procedure and further product marketing.

Regulatory trends tracking and scientific advice

In case a client has already created the clinical development program or a planned study design, Synergy’s regulatory support specialists in collaboration with medical writers and biostatisticians would review and discuss the current program/study and provide consultancy as needed to ensure the success. Given that we have an extensive and high-quality contact base of investigators with whom Synergy deals with in the course of clinical trials, we could also provide a client with scientific advice of the appropriate medical specialist in a definite therapeutic area in a selected geographic region.