• Preclinical pharmacology/toxicology programs to support    Phase I clinical trials
  • Expedited regulatory mechanisms
  • Regulatory strategies to gain competitive advantage
  • Rapid and uninterrupted clinical development
  • Human subjects protection
  • Strategies for combination products
  • Leveraging discovery research
  • Meeting with the FDA



Access BIO is a consulting group which specializes in assisting in the development of drug, biologic and medical device products.

Our experience as policy makers at the FDA, in particular The Center for Biologics Evaluation and Research (CBER), as well as our broad consulting practice allow us the ability to offer our partners advice on the best regulatory strategies and in the development of rational scientific preclinical and clinical approaches to meet the scrutiny of the FDA and other regulatory authorities.   This experience extends to many aspects of biomedical research and product development including vaccines, cellular therapy, gene therapy, blood products, biotechnology products and Institutional Review Board (IRB) participation.   Our experience also includes tissue and plant-derived products.

Let us help you in developing the best approach and well-defined protocols in the clinical and animal studies to speed FDA product approval.

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