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.
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.