Pre – Clinical Development

Preclinical studies are an important step in the product development process. The purpose of the pre clinical development phase is to produce a comprehensive set of data regarding the drug / device / procedure safety and efficacy. It is intended to support the regulatory requirements as well as provide a rationale basis for the clinical development plan selected for your product.

B.R.D. combines its regulatory and scientific knowledge in order to prepare the pre-clinical programs that take into account the unique properties of the product. Conceptually, we try to reduce the number of studies required to support the clinical investigation but to design a pre-clinical plan which can significantly strengthen and shorten the time to regulatory submissions (IND, IDE, CTA etc.)

Core services include:

  • Evaluation and assessment of preclinical programs and data packages
  • Design of preclinical studies (Toxicology, Pharmacology, ADME, Biocompatibility, Efficacy animal models)
  • Providing preclinical plan required to assess the safety and efficacy of a new product to enable submission for clinical trial   
  • Evaluation and selection of preclinical CROs and contract laboratory organization(s) 
  • Preparation of Study Protocols (GLP & Non GLP format)
  • Experimental project management and/or  monitoring testing sites
  • Analyze and interpret clinical pharmacokinetic data utilizing computer modeling programs
  • Study and summary reports preparation (GLP & Non GLP format)
  • Preparation of preclinical section in CTD module format and for distinct development approaches: Orphan drugs designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) applications 
  • Conduct GLP audits of facilities, studies, data and reports.

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