Regulatory Affairs
BFC is a highly experienced guide through all regulations in the Life Sciences industry. Our professionals support you in any stadium of your journey.
Human Medicinal Products
BFC is involved in regulatory procedures for a wide variety of drugs and medical devices and is fully acquainted with the EU Directives. The company is responsible for regulatory affairs matters, including product life cycle maintenance, of a significant number of global companies. We are often involved in European Centralized Procedures, Decentralized Procedures (DCP) and Mutual Recognition Procedures (MRP).
Over the years BFC was involved in CE marking procedures for various types of substance based medical devices as well as in safety evaluations of cosmetics, biocides and food supplements.
Regulatory Processes
BFC is familiar with all documentation required for regulatory processes (including nonclinical, clinical and quality overviews) and developing technical manufacturing files. Other areas of the company’s expertise are support to the national clinical trial applications and simplified reimbursement procedures for registered medicines.
Regulatory support activities are provided inhouse such as e-CTD publishing, medical translations, QC reading of artworks and variations.
EUdraCON Partnership
BFC has partnerships with consultancy companies throughout Europe within the EUdraCON network. BFC is fully acquainted with all possible EU directives involved. We support or advice on regulatory processes.
Benefits
- Strong partnerships
- EU directives
- CE marking procedures
Regulatory Affairs
Quality Affairs
Pharmacovigilance
Market Access Program