From product discovery through post approval, CBR International Corp. provides comprehensive services in program development for biologics, drugs and medical devices. More than just “outside” consultants, we prefer to work as integral members of your development team, offering guidance on issues ranging from product development and manufacture to preclinical and clinical testing, regulatory approval, and post-approval protocols.

As your company contemplates clinical testing of a promising new agent or device, the need for a comprehensive and organized plan leading to regulatory submissions becomes apparent. Our consultants can aid in the creation of in-depth tasks and timelines to meet both your corporate objectives and Agency requirements. As a member of your team, we can assist in the creation of a clinical development plan that incorporates the potential of your investigational product, opportunities for accelerated approval, and a long-term marketing strategy. We provide guidance on product-related issues such as quality manufacturing for Active Pharmaceutical Ingredients and/or final dosage forms, the development of specifications and analytical methods, and the establishment of appropriate stability programs.

The staff at CBR International will explore the requirements for preclinical safety and toxicological testing, review protocols, and suggest timelines that are appropriate for your clinical development plan. We can also assist in the design and outline of clinical trials, from Phase I safety and tolerability studies through pivotal Phase III protocols. CBR Consultants and affiliates have extensive experience developing clinical programs, protocols and all study documents. Furthermore, our staff has been extremely successful in assisting companies with negotiating accelerated development programs with the FDA.

CBR International has developed robust templates for all areas of clinical, regulatory, manufacturing and quality operations. We provide technical writing services for the preparation of regulatory submissions, including Agency meeting request letters, packages and applications. In addition, our consultants can serve as the authorized regulatory representative and FDA contact for your program. CBR International maintains a broad network of expert contacts in all areas of product development to meet your program’s needs.

Specific Consulting and Development Experience

Consistent, thorough and up-to-date analysis of your evolving needs is just the beginning of our commitment to your program. For a comprehensive assessment of your program requirements, please contact us by calling (720) 746-1190 or by email at info@cbrintl.com.