Regulatory affairs, pharmacovigilance and market access services in Russia

With a team of professional, experienced consultants based in Russia, Grove is a highly-respected provider of regulatory affairs, pharmacovigilance and market access consulting services.

Across the board, the regulatory procedures and systems through which a prospective marketing authorization holder (MAH) in Russia is expected to work can at best be challenging. Registration procedures are complex and lengthy, and understanding the increasingly complicated and demanding regulatory and local pharmacovigilance requirements is a test for the most experienced. Legislative change reinforces the need for an in-depth understanding of the current and future expected reimbursement system and the development of an appropriate approach to pricing and reimbursement submissions. Access to a local regulatory partner in the Russian market and to local QPPV services is an essential pre-requisite to executing successful market entry and development.

Across the board, the regulatory procedures and systems through which a prospective marketing authorization holder (MAH) in Russia is expected to work can at best be challenging. Registration procedures are complex and lengthy, and understanding the increasingly complicated and demanding regulatory and local pharmacovigilance requirements is a test for the most experienced. Legislative change reinforces the need for an in-depth understanding of the current and future expected reimbursement system and the development of an appropriate approach to pricing and reimbursement submissions. Access to a local regulatory partner in the Russian market and to local QPPV services is an essential pre-requisite to executing successful market entry and development.

As a specialist healthcare consulting firm, Grove’s expertise in the Russian market spans four key areas:
  • regulatory affairs consulting, including regulatory intelligence
  • pharmacovigilance services
  • market access, including pricing and reimbursement applications
  • market assessment including opportunity evaluation, regulatory risk assessment and intelligence on medical device regulations

GROVE AS YOUR PARTNER IN RUSSIA FOR REGULATORY AFFAIRS, PHARMACOVIGILANCE AND MARKET ACCESS

For over twenty years Grove has successfully provided regulatory, PV and market access services to a wide range of clients to help them navigate the specifics of the Russian market. With experienced locally based consultants, clients gain access to an unrivalled depth of local knowledge and understanding in all areas associated with entering and operating in the Russian market.

Pharmaceutical consulting, regulatory affairs, pharmacovigilance, market access and market assessment services are all key areas of Grove expertise.

Grove services client needs across the following product areas:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Cosmetics
  • Food and dietary supplements