Best Care Consulting GmbH
Global expertise in Pharma & Medical Device Industry
Best Care Consulting (BCC) is a well established consulting company based on two pillars Pharma and Medical Device providing expertise in product development, QM, Audit, Training, Regulation and more.
BCC is based within a large network of trusted professionals, looking for easy solutions, to get to target in a fast moving
environment.
On a personal level, we offer various training sessions and workshops. In some cases, we take on mentoring, giving guidance for personal development. Besides our own industrial experiences, we are able to tackle and tailor or our expertise to our customer's need.
Pharma
BCC provides a broad breadth of knowledge and expertise in managing Global Pharmacovigilance activities across all stages of global drug development for all safety related activities and documentation for pre and post marketed products DSURs, PSURs, Risk Management Plans, CDSs at any stage during Life Cycle of a Drug, Managing Risks and optimizing Benefit/Risk of Products. BCC conveys innovative approaches to Signal Detection and Data-Mining.
Medical Device
BCC is a highly recognized partner which can assist you with a wide variety of Regulatory, Quality Management, Quality Assurance, Clinical and Distribution issues. We are specialized in
regulatory standards such as:
ISO 13485, EN ISO 14971, FDA QSR 21, CRF 820, DIN EN 62366 under consideration of MDR 2017/745 or IVDR 2017/746;
we have expertise in:
- MDR / IVDR conversion
- Quality Management System
- Risk Management EN ISO 14971
- Usability DIN EN 62366-1
- Supplier Quality Management
- Regulatory affairs
- Qualification & Validation
- Post-Market-Surveillance
- Product Maintenance
- Due Diligence examination
«The well-being of humans is more than only lipservice»
CH-REP
BCC is carrying out the function as a Swiss Authorized Representative CH-REP.
Based on our quickly acquired knowledge, a complete Manual has been developed which includes the all the business requirements regarding CH-REP and will be updated based on new information.
The Manual describes the complete process, step by step, for obtaining all written updates from our mandated foreign manufacturers.
Our cooperation and in particular the deputization (incl. PRRC) is regulated via contract which has been tailored specifically for the company and product as required per Swiss regulations. All the steps are document across the process in a clean manner.
Our current process passed the test by a recent inspection by Swissmedic.
(Swissmedic is currently carrying out a large-scale spot check of many CH-REPs).