Preclinical Consulting for Drug Development
Key elements of BRC's approach to creating and managing preclinical drug development paths include:
  • Board certified toxicologists with direct experience in planning and supporting preclinical programs;
  • Confidential competitive bidding process in sourcing genotox, tox, and other special safety studies;
  • eCTD compliant study reports to enable your IND and NDA;
  • GLP monitoring;
  • Proprietary project management system for timelines and deliverables;
  • And more...

The Right Path

The Right Preclinical Path
  • BRC's expert teams have a depth of experience with: different FDA divisions; safety, efficacy, labeling and quality issues; and a broad spectrum of intended drug use categories.
  • Add this to BRCs knowledge of current drug regulatory requirements, and these are the elements that define the Right Preclinical Path for cost/time efficient preclinical development.
BRC Alignment with Evolving FDA Perspectives
  • BRC ensures client projects are based on both (a) the unique aspects of your new drug and (b) the evolving FDA perspectives relevant to your drug development project.
  • Working with BRC helps ensure that essential questions that impact program timing and costs are formulated approp-riately when asking for FDA feedback. 

A Wider Scope

BRC leadership experience spans large pharma companies as well as entrepreneurs in University medical center settings and private practice.
  • BRC leadership has worked for pharma companies and identifies with larger company imperatives regarding project management and cost containment.
  • BRC leadership has also worked in academic settings and understands how to link development plans with investor expectations.  (See Entrepreneur's page.)
BRC's leadership and teams have broad experience across disease and health conditions, which inform decisions about the scope/extent of designs for preclinical programs.  E.g.:
  • ​Acne
  • Actinic Keratosis
  • Allergies
  • Arthritic Pain and Inflammation
  • Asthma
  • Breast Cancer
  • Caries
  • Cataract
  • Diabetes
  • 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

Preclinical Services

In preparation for IND and NDA submissions, BRC provides the following preclinical services:

Preclinical Development & Regulatory Services
  • Cost- and time-efficient regulatory strategy for each project.
  • FDA meetings/feedback (e.g., PIND mtgs).
  • eCTD compliant reports for IND and NDA submission (e.g., preclinical, clinical, CMC etc.).
  • Compilation of study reports for IND/NDA filing.
  • Site identification.
  • Confidential competitive bidding process.
  • Contract negotiation.
  • Proprietary project management process for client reports on costs & timelines.
 
Preclinical ICH/FDA-compliant Studies
  • Preclinical Development path to evaluate carcino-genicity, genotoxicity, TK/PK, tolerability, short and long term toxicity, reproductive toxicity, phototoxicity, organ toxicity (e.g., hERG binding assay), drug-drug interactions, and metabolic pathway.
  • Preclinical regulatory path for biotechnology products
  • Preclinical study protocol development, review &  approval.
  • Preclinical studies for biotechnology products.
 
Preclinical Test Materials
  • GLP or GMP compliant API synthesis.
  • GLP or GMP preclinical formulations (e.g., oral, dermal, iv, etc.).
  • GLP documented monitoring of preclinical studies and test sites audits.
  • Validation of analytical methods for API synthesis & GLP/GMP formulations.
  • Analytical method transfer to preclinical sites.
  • Comprehensive CMC reports for assay of and protocols for API, impurities, heavy metals, mercury, residual solvents, stability, chiral purity, impurity characterization (if needed), among others.