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.
Grove provides a full package of regulatory consulting services related to registration procedures, regulatory approvals and marketing authorizations for drugs, biologics, medical devices, food supplements and cosmetics in Central and Eastern European countries (Poland, Hungary, Czech Republic, Slovakia, Romania, Bulgaria, Slovenia, Croatia, Latvia, Lithuania, Estonia, Serbia, Montenegro, Kazakhstan, Georgia, Armenia and Russia). The main competence of Grove local regulatory affairs specialists is in obtaining and maintaining Marketing Authorizations on behalf and for western pharmaceutical and medical device companies. Grove regulatory consultants advise and assist clients in the preparation of any applications and submission of registration dossiers necessary to this end, so that they are complete and in compliance with the national regulations in force and with all the requirements of the local health authorities.
The scope of Grove regulatory affairs consulting entails submission of packaging and labelling updates, core variation packages for Type IA, Type IB, Type II applications, administrative changes, changes to CMC, Non-clinical, Clinical, clinical trial core document packages, NCE new or abridged dossiers, national regulatory intelligence and translation services.
Grove local regulatory affairs consultants submit to the national authorities all of the information and documentation necessary for the marketing of the products in the country in compliance with the applicable procedures.
Grove regulatory affairs specialists verify that all of the elements relating to the packaging and presentation (labelling i.e. outer packaging and immediate packaging, user instructions etc.) of clients’ products comply with the registration including Product Information, and with the applicable national regulations.
Grove local regulatory experts collect intelligence over amendments to the local legislation and regulations and for all requirements and recommendations issued by the local health authorities, and inform clients of any developments in these areas.
Grove ensures that its local personnel engaged in the provision of the regulatory consulting are competent in the field of local regulatory affairs and have appropriate professional qualifications, training and experience.
Our regulatory services cover verification of promotional materials. We undertake all necessary steps to obtain any required authorizations and communicate such materials to the local health authorities prior to their use. We take the responsibility for verifying the mock-ups of promotional materials provided by Grove clients to ensure full compliance with the following:
- at minimum the requirements of the IFPMA Code of Pharmaceutical Marketing Practices and the legislation and regulations of the local regulatory health authorities that are applicable to them;
- clients’ product Information.
Grove local pharmacovigilance specialists can assume all of the obligations resulting from the regulations on pharmacovigilance with respect to the national health authorities. They can also assume the obligations concerning quality claims.
Upon client’s request, Grove assesses commercialisation requirements in any of the relevant CEE countries and formulates commercialisation and product launch plans for the client.
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)
- 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
- Food and dietary supplements