BIO15PHARMA

About BIO15PHARMA

BIO15PHARMA is an Expertise firm in Quality Management & GxP Compliance – Expert in Transitional Management in the Pharmaceutical, Chemical, Cosmetic, Biotechnology, Medical Device, and CRO industries. Our DNA is to place the patient at the center of each of our projects. We offer an innovative and personalized approach to missions. Our main strengths are: Trust, Adherence, Patient Safety, Responsibility, Simplification, and Results. It is in this spirit that we offer high-end and recognized services in Transitional Management & Consulting. Mission / objective with our clients: * Lead ANSM, FDA, ANVISA… injunction projects to lift the injunction and allow clients to continue to produce, certify, release, and then commercialize their products. * Conduct change management projects through quality processes to clarify and/or simplify their Quality Management System in order to make their QMS Robust, Homogeneous, and Effective. * Lead backlog management projects for deviations to correct discrepancies identified during inspections and/or internal audits. * Lead QMS continuous improvement projects to ensure products of good quality, pure, effective, and safe for the patient. Regardless of your company's size, BIO15PHARMA intervenes in various ways: Transitional Management, strategic project management, crisis management following an injunction, change management through Quality and GxP Compliance processes.