About Biomedical Regulatory Consulting

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BRC was founded by Dr. Bill Soller, an internationally known product development, quality systems, and safety expert with strong credentials relating to FDA regulatory affairs, new product submissions, FDA presentations and interactions, research study design and execution, and quality systems management for drug and device companies, CROs, clinical sites and analytical research labs.

From extensive experience in leading drug and device development teams, Dr. Bill Soller designed the BRC project team system to ensure the reliable deployment of credentialed experts, the application of strong central management oversight, and use of a proprietary quality control system for client deliverables.  

BRC maintains a core of exceptional experts with extensive experience in nonclinical, clinical, CMC and technical engineering aspects of drug and device development.  
For clinical site activities, BRC uses a quality management systems approach created by Dr. Bill Soller for medical center clinical sites that he ran during his time at the University of California San Francisco.
Dr. Soller uses the sample QA principles for medical devices, as further tailored by compliance with FDA's Quality System Regulation in 21 CFR 820.
 ​BRC couples integrated expert teams with strong central management to draw together all the elements needed for your successful cost-effective and accountable regulatory solution.

Clients

• Pharmaceutical Companies
• Medical Device Companies
• CROs
• Clinical Sites
• Analytical Research Labs

For Entrepreneurs

For Entrepreneurs seeking funding, BRC has a special program for complete development of the regulatory nonclinical and clinical study program by timeline and costs.

The BRC Entrepreneur's Drug and Device Development Report™ includes a complete timeline for your drug development research along with specific study costs and informed estimates as to what studies will or will not be required by FDA, or permitted to be delayed until post approval.

Value Proposition - The BRC Difference

BRC uses a proprietary quality management approach for all services. This ensures that: (a) client expectations are clearly defined and agreed upon; (b) team member expertise is matched to the project's various phases; (c) client needs are strategically aligned to federal and international regulations and guidances, (d) rigorous project management tracking and reporting occurs; (e) compliant documentation is created for all study reports; and (e) quality audits are done for all final client deliverables. 

BRC team members are experienced in the nonclinical, clinical, technical and regulatory sciences, with credentialed expertise in: 
  • Regulatory Strategy:
    • Applied knowledge of FDA's expectations for nonclinical, clinical and technical studies across many disease categories.
    • ​ Regulatory pathway support for nonclinical, clinical and technical research to enable IND and NDA approvals and 510(k) clearance and PMA approval.
    • ​Successful management of FDA communications, submissions and meetings.​
    • Effective project management.
  • Devices Development:
    • Device testing supporting design verification and validation, safety (biocompatibility), risk management, software specifications and validation, human factors/usability (engineering) testing; postmarketing studies and surveillance.
    • 510(k) and PMA Submissions.
  • Drug Development:
    • Protocol development
    • CMC: development API synthesis methods, stable test material formulations for GLP and GMP studies, technology transfer and scale-up.
    • IND and NDA Submissions.
  • Quality Systems Management
    • Development and renovation SOPs for compliance with of Quality Systems Management requirements. 
    • Internal and External Auditor: CROs, clinical sites, pharma and device companies, analytical research labs.