ABOUT OUR TEAM - FOXYMED is a team of 4 partners and employees who have more than 25 years of combined experience in the pharmaceutical industry. - FOXYMED is multilingual team with French and English native speakers MEDICAL AREAS OF EXPERTISE AND ENPERIENCE - EXPERTISE: Neurology, Psychiatry, Diabetes, Respiratory diseases, Gastoenterology - STRONG EXPERIENCE: Rheumatology, Virology and Cancerology - OTHER PROJECTS: Cardiovascular diseases, Haematology, Urology, Tropical diseases, Dermatology ACTIVITIES 1) MEDICAL WRITING - Preparation of scientific articles and publications (Research for articles, Review articles, Epidemiological articles) - Congress Posters - Slide kits: Development of scientific presentations for conferences symposiums or congresses, Presentations for experts meeting or medical education 2) WRITING OF REGULATORY DOCUMENT FOR DRUGS - AMM: NDA dossier, Product Core Dossier (modules 2.5 & 2.7s), EMA Referral, Medico-Economic dossier, CER for Medical Devices, Clinical overview for type II variation - Safety & Efficacy documents: BR (PSURs) & PBRER, Addendum to clinical overview (Aco) - Clinical & research documents: Clinical overview, Clinical expert statement (CES), Clinical study report (CSR), Investigator’s Brochure, Study protocols, RMP, Answer to health authorities 3) ACCOMPANYING CLINICAL TRIALS 4) COMPETITIVE INTELLIGENCE Literature review can be provided by FOXYMED, often as a part of one of the above described projects, but also as a separate document (Medline searches, Digests, Preparation of syntheses, Critical appraisal, Clinical & research documents) 5) EXPERTS & ADVISORY BOARDS MEETING - Organization & logistic - Slides & documents with scientific content - Meeting report - Symposium report in scientific journals - Following project 6) CONSULTING & MANAGEMENT - Constitution of scientific advisory boards - Recommendation for publication strategy - Participation in project teams