News Careers Contact us REGULATORY HOMEPAGE SERVICES REGULATORY Famar’s Regulatory Affairs Team has extensive experience in providing support in Scientific and Technical Regulatory Affairs writing, Regulatory Gap Analysis as well as, Regulatory Affairs submission strategy proposals. In direct collaboration with its customers, Famar defines the best regulatory strategy for their product portfolio for a smooth entry into the foreseen markets, to overcome any regulatory challenges with accuracy and efficiency and offers its continuous support during products regulatory life-cycle management. Scientific writing: CTD Famar’s Regulatory Affairs experts compile medicinal product quality information in the CTD format for submissions on behalf of their customers and marketing authorization holders. Regulatory affairs specialists provide advice, technical scientific due diligence of registered dossiers for quality and completeness, prepare and review dossiers and keep them up-to-date at all times according to thecurrent legislation. Read More Technical writing: Non-pharma products (cosmetics, Biocides, Medical Devices, Food Supplements) Organizing customer’s data and other technical information for their cosmetics (PIF), Biocidal products, Medical Devices (Technical dossier) and Food supplements will help them maintain their product in Europe while meeting the European market requirements. Famar’s Regulatory Affairs team will compile in specific templates the technical data sheet and/or specifications and all the quality related information for its customers’ products. Read More Gap Analysis 1) Regulatory Gap Analysis A regulatory gap analysis is the comparison of two dossiers either of medicinal products (Module 3 vs Module 3) or of non-medicinal products. Famar’s regulatory affairs team will assist in flagging gaps and identifying differences between two or more regulatory dossiers and tailor the regulatory gap analysis according to the customers’ needs and intended scope. Read More Regulatory Affairs Submission Strategy “To improve is to change; to be perfect is to change often” and this is very applicable in the pharmaceutical world. Changes, however, lead to variations and submissions of new dossiers. A regulatory/submission strategy will always safeguard Famar’s clients with the authorities’ requests and needs. For any change they want to perform to their product, Famar’s Regulatory Affairs team will prepare a Regulatory Submission Strategy Proposal. The RA team will identify the type and the number of the variations needed, flag potential pitfalls and conditions and identify the appropriate documentation (CMC and extra documents) required to be submitted. Read More Follow-up until approval by HA and help to respond in requests and Deficiency Letters For any quality related extra requests or responses to Deficiency Letters with regards to quality matters, Regulatory Affairs team’s expertise, and broad network of experts within Famar, will assist its customers to overcome any additional authority request. Read More NEWSLETTER SUBSCRIPTION Enter your email address I have read and accepted the Privacy Policy OR FOLLOW US: Privacy Policy Terms of use Cookies Policy Careers © FAMAR Health Care Services Design by Sheepfish