I have the knowledge, skill, experience, training and education to provide high quality, recognized and respected litigation support and regulatory consulting.

• Resume (Microsoft Word)
• Fourteen years with the Food & Drug Administration making and managing civil, administrative and criminal cases
• Highly trained and extensively experienced in a broad range of investigative techniques, including auditing, interviewing, and data analysis
• Master's of Science and Doctor of Law Degrees
• Food & Drug Law Professor
• Eighteen years of invited speaking and lecturing engagements to industry and academia
  Publication in an expert treatise on Drug Injury, including original research and analyis of FDA enforcement procedure
• Ten years experience providing Litigation Support, Expert Witness, and Regulatory Consulting Services

Representative Litigation Support Cases

Medical Malpractice: Corporate client's employee accused of using unaaproved invasive medical device.  My research proved that device had been approved by the FDA , and was lawfully marketed in the United States.

Breach of Contract: Assisted corporate client in prosecuting breach of contract suit and defending cross complaint. Inspected pharmaceutical manufacturing facility, conducted GLP inspection and evaluation of testing laboratory, and reviewed and evaluated bioequivalence and bioavailability studies.

Breach of Contract, Expert Witness: Provided expert witness services on issues of device pre-approval, GMP's, and product failure analysis in a latex glove case.

Qui tam: Assisted plaintiff's attorney prepare whistle blower case against Clinical Investigator  for violation of GCP's and Informed Consent regulations.

REPRESENTATIVE REGULATORY CASES

Clinical Investigator: Reviewed and analyzed FDA Warning Letter.  Drafted response to warning letter including corrective action plan.

Contract Monitor: Reviewed and analyzed numerous FDA Warning Letters to Monitor and Clinical Investigators.  Assisted Monitor in responding to warning letters including corrective action plans.

Pharmaceutical Company: Reviewed and evaluated company's GMP's and SOP's, and helped to design corrective action plan to settle FDA seizure action.