Best Care Consulting GmbH

Global expertise in Pharma & Medical Device Industry - Investment Portfolio -           

Bridging Networks      

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 and investors, 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»

MSC-INHP

Furthermore, BCC in fellowship with MSC-INHPs we conduct research work i.e. Benchmarking benefit / risk profiles of current drug therapies and review of drug approval processes by various regulatory authorities and gap analysis e.g. biosimilars. Our focus is mainly on the current cancer therapy, regulatory requirements in context of old and new emerging products and patient safety.

Our results are communicated to the public i.e. health care professionals and patients via participation and presentations at various training sessions and workshops as also in conferences e.g. ASCO, DIA or other  public Hearings.