Mission & Objectives
Accelerating development to create lasting impact.
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BRC Mission - US, EU, UKBiomedical Regulatory Consulting accelerates access to safe, effective, high quality medicines and medical devices by applying expertise in drug regulatory affairs, medical device regulatory affairs, clinical research, clinical site management, and project management, in order to create and manage accountable, credible and reliable regulatory paths to market.
BRC does this by engaging development teams with qualified experts in all nonclinical, clinical and/or technical aspects of drug development, medical device development, and clinical site management. BRC has a reciprocal partnership contract with an experienced EU and UK consultancy company who is available to support our clients who need the regulatory and quality compliance required to bring medical device products to the international market. To access this partner, see contact page. |
BRC Objectives
- Expand and/or maintain access to safe, effective and properly labeled medicines and medical devices.
- Apply risk management principles to drug and device safety assessments to identify appropriate regulatory pathways to support successful market introduction and continued marketing.
- Establish quality as a principle driving day-to-day activities at clinical research sites and manufacturing facilities supporting drug and device development.
- Apply proprietary time/project management and budgeting processes to serve clients needs for accelerating product development phases, regulatory reviews, and market introductions.
