Industry

Bioteknowledge Consultants have held executive management positions at many Fortune 500 Pharma and Biotech Companies and the Food and Drug Administration. They have experience shepherding the drug development process from R&D through clinical trials and on to post-licensing and marketing.


Academic

Our consultants have advanced scientific degrees, and some have held professorships. They have authored papers, abstracts and have given presentations on pharmaceutical chemistry and drug molecular structure, assay development and validation, and economics in the drug business.


Regulatory

Our consultants have authored regulatory documentation (IND, BLA, CMC sections, EU Expert Opinion Report etc.) for the registration of new drug products.  They have presented talks at scientific and industry meetings and to regulatory agencies both in the United States and abroad on drug structure, assay development, validation, QA/QC, regulatory and economic aspects of drug development.  They have defended clients in meetings at the FDA and overseas and have worked with FDA officials to rectify 483 issues, regulatory strategies and other issues. 


Professional Organizations

Our professionals belong to many scientific and professional societies, including:

  1. •Regulatory Affairs and Professional Society (RAPS)

  2. •American Chemical Society

  3. •The Protein Society

  4. •American Association for the Advancement of Science

  5. •New York Academy of Sciences

  6. •American Society for Mass Spectrometry

  7. •Association of Biomolecular Resource Facilities

  8. •California Separation Science Society


Bioteknowledge is a Member of the 

Chem Consultants Network of the American Chemical Society

Experience