New members
Welcome Bio15Pharma to the FACCNE Community!
We’re thrilled to welcome Bio15Pharma to FACCNE, bringing deep GxP, quality and compliance expertise to the pharmaceutical and life sciences community
BIO15PHARMA is a GxP Quality and Compliance Management Consultancy - Expert in Transition Management in the Pharmaceutical, Chemical, Cosmetics, Biotechnology, Medical Device and CRO industries.
Since 2015, companies in the pharmaceutical sector have been faced with numerous ANSM and FDA injunctions. These all have in common a failure of the Quality Management System and/or a very significant disregard for Good Manufacturing Practices (GMP). These regulatory requirements apply to all players in the medical field: chemical, cosmetics, medical device, CRO and biotechnology industries.
In light of this, Bio15Pharma is committed to offering you effective, personalised services that enable you to pursue a fundamental objective : ENSURING PRODUCT QUALITY TO GUARANTEE PATIENT SAFETY.
Working with our customers :
- Within 24 hours, we can intervene anywhere in France, Europe, and the rest of the world to find the interim manager you need.
- We have listed 3,600 Interim Managers - Experienced experts with over 10 years of experience in the pharmaceutical industry who will help you bring your projects to fruition.
- Managing projects to implement Quality Management Systems up to and including GMP and/or ISO 9001 certification. Establishment of pharmaceutical and chemical subsidiaries, Supplier Quality Audits
- Managing ANSM, FDA, ANVISA injunction projects, etc. to lift the injunction and authorise clients to continue producing, certifying, releasing and then marketing new products , Formation GxP, Habilitation GMP.
- Carry out change management projects across quality processes to clarify and/or simplify their Quality Management System to make their QMS robust, consistent, and efficient.
- Leading projects to process the deviation backlog in order to correct deviations identified during inspections and/or internal audits.
- Leading QMS continuous improvement projects to guarantee good quality products that are pure, effective, and safe for patients.
- Steering of ANSM / FDA injunction projects
- Implementation of Electronic Document Management (EDM) systems, Deviation backlog management,
- Implementation of electronic batch records (DLE), GxP Audit, Training and certifying internal auditors,
- Guaranteeing the decontamination of your zones
- Implementation of remote inspection management solutions (ANSM, FDA, ANVISA, etc.)
For more information: https://bio15pharma.com
Contact:Nadjim.Mhoma(@)Bio15Pharma.com
