​Lists of BRC's Drug & Device Development Services - Overview

Drug Development
​

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

Device Development

Comprehensive Device Regulatory Affairs
  • Regulatory pathfinding.
  • Government agency interface and communications.
  • Agency Meetings: inform-ational and presubmission meetings and related communications; issue-specific meetings.
  • 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. 

Quality Management Systems (QMS)

Targeted to Start-up Drug and Device Companies, and Clinical Sites/CROs with emphasis on the needs for Quality Management Systems to meet regulatory compliance and to achieve best business practices.

QMS Services
  • Quality Management System - (QMS), proven and tailored to your organization.
  • Gaps Analysis of internal operations and procedures
  • Internal Audit Procedures & Preping for External Audits.
  • Key Job descriptions, matched to performance tracking.
  • SOP Manual - creation or renovation of existing manual.
  • Quality Event Investigation (QEI) methods using root cause analysis and corrective action plan framework.
  • 483 Replies & Management. 
  • Staff training in QMS.
  • Efficient Network-based Employee Performance Tracking processes for efficient network-based assessment for group or individual reviews.  ​
  • For clinical research: QA Templates adaptable to each clinical study, or to each drug or device development program.
  • ... and more.