BRC's FDA Drug & Device Development Services - Overview

For EU and UK services from BRC's int'l partner, see ​Contact Us.

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Drug Development
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Comprehensive Drug Regulatory Affairs

• Regulatory pathfinding
• FDA meetings & communciations.
• FDA Feedback (e.g., PIND, End of Phase 1, End of
  ​Phase 2, Pre-NDA, Dispute Resolution mtg., etc.).
• Postmarketing Services.

Development Program Pathfinding

• Comprehensive program definition and pricing.
• Confidential competitive. bidding for outsourced studies.
  
• Preclinical program - tailored to efficiently enable your IND.
  
• Clinical Program Phases I, II, III. 
  
• Full CMC regulatory services.
  

Drug Submissions

• Investigational New Drug Applications (IND).
• New Drug Applications (NDA).
• Abbreviated New Drug Applications (ANDA).
• Rx-to-OTC Switch and other OTC applications.
• 505(b)(2) Applications.
• 15-day and annual postmarketing AE reports.

CMC Regulatory Affairs 

• Contracting and management of API synthesis and preclinical and clinical formulations
• QSR compliance

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Device Development

Comprehensive Device Regulatory Affairs

• Regulatory pathfinding.
• FDA interface and communications.
• FDA Meetings: PreSub Program Mtgs., Informational Mtgs., Submission Issue Mtgs.
• Postmarketing services - medical device defect management & reporting.
  

Medical Device Applications and Submissions - Writing and Submitting

• 510K Premarket Notifications and Tird-Party Reviews.
• Premarket Approvals (PMA).
• Investigational Device Exemptions (IDE).
• Humanitarian Device Exemption (HDE).
• Study Risk Determinations.

Quality System Reviews

• Quality System Regul-ations (QSR) compliance assessments.
• QSR Plans.

Tailored Device Support Activities

• Complete regulatory analysis of program targets and costs.
• Technical Studies including design, implementation and analysis.
• Usability & Human Factors Studies: design, implementation and analysis.
• Clinical validation Studies: design, implementation and analysis. 

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Quality Management Systems

Targeted to Drug and Device Entrepreneurs and Clinical Sites/CROs with emphasis on needs for:  Quality Management System for regulatory purposes and to achieve best practices of the industry.

QA/QC Clinical Site Services

• Quality Management System - (QMS) - proven and tailored to your site.
• Certification of facility audits.
• Key Job descriptions, per current Human Resource practices.
• Methods for QA/QC Gaps analysis using a QM systems approach. 
• QA Templates for use in tailoring to each clinical trial, each product development program, and each product post marketing.
• SOP Handbook - creation or renovation of existing handbook.
• Quality Event investigation plans using root cause analysis and corrective action plan framework.
• 483 Replies & Management. 
• Staff training in quality systems approach to QA/QC for clinical trials.
• Efficient Network-based employee performance tracking process.  ​

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