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Your partner in CTD & eCTD files - Variations - Risk Management Plan - Environmental Risk Assessment - Preclinical and Clinical - PIL user testing - CEP and ASMF applications - National and DCP MAs - MA Holding - MA Transfer - ICH Q3D Risk analysis - Reimbursement and prices - Market access studies - Consultancy and Quality action plan - Qualification and Validation - Coaching and Communication - GMP training sessions
Pharmaceutical Directory
A 3-day intermediate level Workshop using a top-down approach with a strong mechanistic emphasis. This intermediate level workshop is designed for those engaged in pharmacokinetic studies in drug discovery, development and regulatory assessment, who already have a good working knowledge and understanding of the basic physiological and mathematical concepts and applications in the subject area, for example, who have taken the Basic Pharmacokinetic Workshop, Arosa.
10th – 12th October 2018
Villa Modigliani - Paris – France
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Your partner in Regulatory Affairs, Pharmaceutical Development and Project Management.
Created in 1990, Stratégie Santé is an independent French company providing Assistance and Advisory services to Pharmaceutical Laboratories with full confidentiality. Thanks to our proven expertise in Pharmaceutical Development and Regulatory Affairs, we support our clients throughout all phases of the product development, including occasional issues.
Our responsiveness and our flexibility assures our clients a customized service of high quality. Our know-how enables us to manage projects by reconciling clients expectations and regulatory requirements, while optimising costs and meeting deadlines.
Stratégie Santé helps their clients to achieve the best development strategy, whatever the pharmaceutical form is. We take charge of each stage of a project providing our technical expertise. We select and coordinate all subcontractors from the raw material sourcing through to the manufacturing of the registration batches, including the completion of the technical part of the dossier.
Our regulatory expertise enables us to advise our clients to achieve the most efficient registration strategy. We provide writing services for CEP, ASMF and MA dossiers (CTD and eCTD) and their submission, including their follow-up throughout the product life cycle. In addition to the audit of dossiers, we propose MA holding and transfer.
Together with our partners, Stratégie Santé offers services on Quality audits (raw material suppliers, manufacturing subcontractors, distributors…) and assistance in Preclinical and Clinical Development (audits existing files, preclinical and clinical plans, trial methodology and management, reports…), Quality actions Plans (Qualification and validation, training all people, coaching and communication), and France/Europe Market Access expertise for pharmaceutical specialties and Medical Devices (decision-making assistance for reimbursement applications and price negotiations, files for therapeutic value assessment, and Market Access studies).
Furthermore, Stratégie Santé is a member of Regulanet®, an international network providing us a privileged access to Regulatory Affairs and Pharmaceutical Development experts in over 90 countries throughout the world.
Stratégie Santé
19, rue Georges Clemenceau
78000 Versailles - France
Société agréée au titre du
Crédit d'Impôt Recherche et du Crédit d'Impôt Innovation
Tél. +33 (0)1 42 86 86 00
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