BRC Consulting for Clinical Phases I, II, III
BRC engages as a reliable regulatory accelerator by blending regulatory and research to cost-effectively enable INDs and NDAs.
  • Clinical programs are designed on the basis of: the broad disease state expertise of BRC development teams; historical FDA regulatory patterns and precedents; and evolving policies and guidances.
  • Preclinical programs are linked to the clinical program by the appropriately defined scope and extent of nonclinical safety and toxicology testing to enable INDs cost-effectively.
  • BRC leadership and teams have a wide scope of experience across many different diseases and are qualified experts in understanding the regulatory nuances of drug development. 
  • BRC uses its confidential competitive bidding process and accountable time management system to ensure cost-effective clinical and nonclinical programs.  

BRC's Disease State Experience

  • Acne
  • Actinic Keratosis
  • Allergies
  • Arthritic Pain and Inflammation
  • Asthma
  • Breast Cancer
  • Caries
  • Cataract
  • Diabetes
  • Drug-induced side effects
  • Drug-induced side effects
  • Drug-induced hypersensitivity reactions (DRESS, EM, SJS, TEN).
  • Genital Warts
  • Gingivitis
  • Glaucoma
  • Halitosis
  • Hemorrhagic Stroke
  • Hyperlipidemia
  • Liver Diseases
  • Lung Cancer
  • Migraine
  • Myocardial Infarction
  • Neuropathic Pain
  • Perennial Rhinitis
  • Reye Syndrome
  • Seasonal Allergies
  • Sinusitis
  • Tension headache
  • Thromboembolic Events
  • Thrombotic Stroke
  • Transient Ischemic Attacks
  • URI/Common Cold
  • Vasculitis
  • Among others.

Overview of Clinical Regulatory Services

Clinical Drug Development/Regulatory Services
  • Cost- and time-efficient regulatory strategy for each project.
  • FDA feedback/meetings (e.g., PIND, End of Phase 1, End of Phase 2, Pre-NDA, Dispute Resolution mtgs).
  • eCTD compliant reports for IND and NDA submissions (e.g., preclinical, clinical, CMC etc.).
  • Clinical site identification, contract negotiations, confidential competitive bidding process.
  • Assurance of FDA-compliant clinical study reports and associated materials. 
  • IND/NDA submission preparation and filing.
 
Phase I, II. II Planning & Pathfinding (Highlights):
  • Use of the Target Product Profile or similar strategic document for agency discussions.
  • Identification of cost-efficient scientifically-sound study designs.
  • Identification of sites, confidential competitive bidding process.
  • Agency engagement for FDA feedback (e.g., PIND, End of Phase 1, End of Phase 2, Pre-NDA).
  • Proprietary project management process for client reports on costs & timelines.

Implementation of Regulatory Programs for Clinical Development - Phases I, II, III.
  • Design, monitoring human clinical studies addressing tolerability, dose-ranging, safety, efficacy, PK, etc.
  • Development of agency-compliant labeling (e.g., full prescribing information, MedGuides).
  • Protocol writing, Investigator Brochures, IRB approval.
  • In-study reporting to FDA, 
  • eCTD compliant clinical study reports - Phase I, II, III. 
  • Study monitoring.

CMC & Manufacturing: 
  • GMP API synthesis and clinical formulations, with validated identification, purity, quality and stability testing. 
  • Tech transfer to scale-up sites.
  • And more.  See CMC page.

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.
  • Postmarketing 15-day and annual reports. 

Clinical Trial Management & Facility Audits