Our areas of expertise
Regulatory Affairs
A partner for all dossier audits, registration strategy,
dossier writing,
management of variations, regulatory maintenance,
and with an experience with specific drugs.
Pharmaceutical Development
Long experience in development strategy, identification of operational service providers, management and coordination of stakeholders, writing of eCTD modules, and client reporting.
Project management
The flexibility of an outsourced project management, a single project manager dedicated to your case with an extensive experience in pharmaceutical development and writing, and a tailor-made service.
Quality and Quality Audits
The quality of specialists in audits of API supplier and pharmaceutical excipients, in process quality assessment, and in development of qualification and validation processes.
Advice and Online support
Answers to your questions on all subjects in our areas of expertise, by phone and email. Strategic analyzes and decision-making aids, connection with specialists and the guarantee of a network.
Advice and Coaching
Advice on upgrading your operational sites, assistance in bringing Quality management and risk management systems into compliance, "Inspection" assistance, and coaching services for the Quality functions of management staff
We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.
Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.
STRATÉGIE SANTÉ
53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00
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