Regulatory Services in Central & Eastern Europe
Grove Group consultants provide a 360 degree regulatory services support and resource throughout all stages of product marketing authorization process in Central and Eastern European countries.

Regulatory consulting in the CEE countries

REGULATORY SUBMISSIONS, MEDICINES AND MEDICAL DEVICE REGISTRATION

Grove is your regulatory affairs specialist in 17 CEE countries and it guarantees efficient MA approval process for medicines, biologics, medical devices, food supplements and cosmetics.
  • Services related to evaluation and support with optimising submission dossiers
  • Submission of documentation for new marketing authorizations and MAH transfers
  • Medical device registration in central and eastern europe
  • Management of a broad range of application types (DCP, MRP, NP) in accordance with the latest requirements
  • Labelling compliance and approval
  • Maintaining close contact with local agencies to monitor ma application progress
  • Review of the local language patient information leaflets (PIL)
  • Carton/label artwork, mock-ups review; full alignment to national requirements
  • Readability testing of package leaflets
  • Packaging material submissions

REGULATORY CONSULTING TO MAINTAIN REGULATORY APPROVAL/MARKETING AUTHORIZATION

Grove Group CEE consultants’ in-depth market knowledge and established contacts with local healthcare authorities enable marketing authorization holders to maintain MA approvals and maximize business performance of medicines and medical devices.
  • Management of existing marketing authorizations throughout central and eastern europe
  • Preparation and management of maintenance applications
  • Submission of variations (manufacturing, labelling changes)
  • Renewals
  • Notifications
  • Safety updates
  • Support for the management of national agency databases
  • Assistance with the submission of annual specific national declarations
  • Support for compassionate use programs

GROVE REGULATORY SERVICES TO MONITOR LOCAL REGULATORY REQUIREMENTS

The full-service regulatory package of Grove Group local consultants includes provision of monitoring services to equip Grove clients (manufacturers of medicinal products, biologics, medical devices and food supplements) with regular updates on national regulatory requirements in the CEE countries.
  • Monitoring changes to national regulatory guidelines and legislation
  • Advise on country specific national regulatory requirements in central and eastern europe
  • Providing expert advice on regulatory strategies for the cee region and individual countries
  • Assess national regulatory documentation and provide appropriate updates
  • Ensure compliance with local regulatory processes in the cee countries given any change in national legislation, regulations and policies
  • Provide relevant safety updates
Key product areas covered:
  • Pharmaceuticals/medicines/drugs/medicinal products
  • Medical devices
  • Biologics
  • Food and dietary supplements
  • Cosmetics