PHARMA BUSINESS CONSULTING

E-mail : regulatory@pharma-businessco.com REGULATORY AFFAIRS Our expertise in negotiations and interaction with the Health Authorities and our mastery of the national and regional regulations of the FSA and ESA, allow us to obtain results within acceptable deadlines, but also to anticipate and avoid all the recurring problems related to the MA files, thus canceling the impact of these on the business of our partners. PHARMACOVIGILANCE Our skills range from Case Management to the Risk Management Plan, including the Management of CIOMS/Safety Reports/PSURs, Answers to Health Authorities, Product Recalls, Market Research Projects, Literature Screening… and all while respecting the Work Instruction of our partners. QUALITY & COMPLIANCE We support our partners in the drafting, revision and the application of their Standard Operating Procedures (SOP) but also in the preparation of internal or external audits with establishment and follow-up of corrective and preventive actions (CAPA) which result therefrom. SUPPLY CHAIN Pharmaceutical logistics presents much higher stakes than that of other sectors of activity. Indeed, more than simple products, the elements transported (drugs, medical equipment, etc.) are crucial to public health. Optimizing inventory management, improving the quality of supply and controlling cost throughout the supply chain sum up all our experience in the Supply Chain. MARKET RESEARCH We have an experienced and dynamic professional team with excellent knowledge of the field and a great understanding of the local market, a mastery of computer tools and a meticulous analytical mind for all kinds of market research.