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B2G Life Sciences is an innovative consulting & contract research organization, dedicated to the pharmaceutical and biotechnology industry. We believe in the opportunity of shortening the distance between the industry products and projects and markets'? unmet medical and scientific needs. Through our presence both in Paris and in Tunis, we endeavor to build bridges and gateways between operators in different regional markets. We offer the following services: - Consulting in medical and regulatory affairs, clinical research and clinical development - Medical affairs and clinical development strategies - Management of data monitoring boards & steering committees - CTA regulatory submissions and follow-up with Regulatory Authorities - Regulatory submissions and follow-up for marketing authorizations - Drug safety and pharmacovigilance - Advice on collaborative networks set up (networking, collaborative project management) - Trainings in the businesses of pharmaceutical industry (ICH-GCP, Regulatory, marketing and communication? - CRO activities - Protocol design and medical writing (clinical protocols, CSR?) - Scientific management of Key Opinion Leader networks - Investigation site identification and selection, clinical feasibility studies - Clinical operations and project management - Monitoring of clinical studies - Services and partnerships in market access, marketing and business development - Regulatory support for market access - Marketing authorizations management, renewals and modifications - Market access and market development - Planning and conduct of marketing actions towards regulatory authorities as well as Key Opinion Leaders - Sales and business development - Medical communication and product promotion - Recruitment, training and management product-exclusive marketing and sales teams - Identification and selection of scientific and industrial partners
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14 rue Charles V
33 (0)1 85 54 01 76