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
- 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.
Benefits
- Experienced
- Focused
- Constant improvement
Regulatory Affairs
Quality Affairs
Pharmacovigilance
Market Access Program