Grove provides regulatory consulting services in relation to the obtaining of regulatory approvals, marketing and sale of pharmaceutical products in Central and Eastern Europe. The main competence of our local regulatory specialists is in attaining and maintaining Marketing Authorisations on behalf and for western pharmaceutical and medical device companies. They 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 our regulatory affairs 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 translational services.
Grove local regulatory affairs experts 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 (labeling 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.
Our local regulatory and pharmacovigilance specialists 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 national regulatory services are competent in the field of 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:
Our 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.