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Expert Witness

Science and Compliance in Support to Counsel

Expert witnesses from Microbiology Network, Inc. are drawn from nationally recognized practioners with experience in the Pharmaceutical, Compounding Pharmacy, Biotech, OTC and personal care products industries.  Many are ex-FDA or current members of USP.  No matter the specifics of your situation, we have someone who can provide expert witness consultation.

Expert witnesses are available  pharmaceutical (parenteral, ophthalmic, sterile and non-sterile), compounding pharmacies (503A and 503B), OTC and personal care products with in-depth knowledge of:

  • FDA regulations and CGMP
  • USP Standards
  • USP <797> and 503B Regulations for the Compounding Pharmacy
  • Contamination Control in manufacturing / sterility assurance and bioburden control
  • Sterilization
  • Aseptic Manufacturing
  • Objectionable Organisms
  • Quality Control Lab Operations

Our principal, Dr. Sutton, has practical experience as an expert witness in patent litigation and product liability cases having provided consultation, data analysis, fact finding and discovery, patent review, expert opinion, deposition and trial testimony.   Best practice, data interpretation and regulatory review are all well in hand with Microbiology Network, Inc.

In addition to personal expertise, our experts are scholars well able to assist in the identification of prior art for your case.

Schedule a call to discuss your needs and find the expert witness you seek.