Quality Affairs

Over the years, BFC has acquired a wide experience in the design and implementation of quality systems. Based on these years we are able to combine this experience and expertise in a particular area with active innovation. Our consultants have the required skillset to support the various types of Pharmaceutical License application projects. These include the implementation of EU-GMP systems in pharmaceutical production facilities, EU-GDP systems in distribution facilities and ISO/EN-13485 systems in medical device companies.

Expert Knowledge

We develop and actualize quality systems for:
  • Pharmaceutical production facilities (GMP/GCP)
  • EU import (GMP)
  • Repack activities (GMP)
  • Distribution facilities, warehousing of finished products (GDP)
  • Distribution of Active Ingredients (API)
  • Medical Device companies (ISO 13485)
  • OTC/Food companies (HACCP)
  • Qualified/Responsible Person services
  • Audit services

Process improvement

On a regular basis BFC was involved in a number of related projects including

  • (Re)Design and new construction of production and distribution facilities
  • Business management analysis of production units
  • Acquirement of licenses for facilities
  • Outsourcing programs for virtual pharmaceutical manufacturers and/or distributors
  • Employee training programs and various validation programs

Each project’s solution is rooted in proven approaches and better than the solution provided on any previous project.


  • Experienced
  • Focused
  • Constant improvement