The BRC Difference
In the complex and costly environment of pharmaceutical drug development, three characteristics distinguish successful drug development programs which mitigate potential risks of delays and cost overage.  
  1. Effective deployment of integrated teams, which draw on mutual strengths of qualified experts to define options and accountability by all team members.
  2. Experienced central management that ensures a quality systems approach to the timely development of reliable data to support all phases of drug development. 
  3. Strong reliable drug regulatory affairs support that ensures submission-compliant deliverables that meet drug agency expectations.   

The BRC Difference

  • Responsive, interactive with a wide scope of practice.
  • Comprehensive services for drug regulatory affairs.
  • Ongoing matching of team expertise at all stages of the product lifecycle.
  • Dependable regulatory path management using a proprietary project management framework.
  • Confidential competitive bidding process for outsourced studies.

Regulatory Experience `~ Past Disease or Condition Categories re Drugs & Devices

  • Acne
  • Actinic Keratosis
  • Allergies
  • Arthritic Pain and Inflammation
  • Asthma
  • Breast Cancer
  • Cardiac arrhythmias
  • Caries
  • Cataract
  • Diabetes
  • Drug-allergies
  • Fuchs Endothelial Corneal Dystrophy
  • 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.  
Medical Devices 
  • Diagnostic devices
  • Surgical Devices
  • Powered Muscle Stimulators
  • Transcutaneous Electrical Nerve Stimulation (TENS) Devices
  • Skin Stimulators for Beauty Enhancement
  • Ophthalmic Devices
  • Mobile Health Applications

BRC Drug Regulatory Services - Overview

Strategic Guidance and Project Management
  • Reliable regulatory path guidance for nonclinical and clinical phases for drug development, and for supporting the development and testing phases of devices. 
  • Full scope regulatory services & project management throughout the product lifecycle.
  • Proprietary project management system designed to meet timeline and budget objectives. 
BRC Regulatory Affairs Services
  • FDA Interactions:  Communications, correspondence, pre- and post-meeting management, meeting logistics, agency presentations.
  • Meeting Packages: Compilation and submission of Meeting Packages (e.g., PIND, EOP2, PreSub).
  • FDA Submissions:  Compilation, preparation and submission of applications [IND, NDA, ANDA; and 510(k) and PMA];
  • FDA Requests:  Preparation and coordination of responses to FDA requests.
Special Services:
  • Protocols & Investigator Brochures:  Writing Investigators Brochure and Protocol.
  • Vendor Qualification: e-TMF, e-Binders, AI suppliers, Clinical Sites, IRBs
  • Postmarketing Regulatory Services:  Safety Reports  (7-day and 15-day, annual).