EERA Clinical's regulatory team is comprised of experts experienced in all regulatory issues. We provide a wide range of regulatory affairs se rvices, including pricing and reimbursement, to our clients. We focus on the client’s needs and requirements, to provide services of high quali ty that meet their expectations.

Flexibility, experience in multidisciplinary projects, excellent relations with Health Authorities and deep knowledge of legi slation and regulatory environment are the major strengths of our department. Our group experts have thorough knowledge current knowledge of regulatory landscape and the individual requirement for submis sion, extensions or renewals.

The regulatory affairs department of EERA Clinical offers a wide range of services to its clients summarized below:

Registration of pharmaceutical products through National, Mutual Recognition and Decentralised procedures. Maintenance of the Marketing Authorisations through variations and renewals. Preparation and submission of Pricing and Reimbursement applications. Control of packaging and promotional material and other marketing related services. On-site placement of regulatory staff according to the client’s needs. Effective deals with the authorities and intensive follow-up in every submission, in order to ensure timely conclusion of the national phase of the procedures. High quality translations of the Summaries of Product Characteristics, Labeling and Patient Leaflet to the local language. Consultancy services concerning the local regulatory provisions and requirements. Consultancy services for medical devices, cosmetics, food supplements, biocides. Training in Regulatory Affairs.