Sharlin Consulting Services

Joshua Sharlin, PhD

Expert Witness, Pharmaceutical Regulation and Medical Devices

Former FDA Reviewer
25+ Years of Consulting Experience with FDA-regulated Companies

Expert Witness Cases

  • For a hip implant, write an expert report describing the manufacturer’s lack of FDA
    compliance in their efforts to obtain a 510(k) approval.
  • Write a report explaining why the Warning Section of the label for a generic version of sulindac was deficient.
  • Assist attorneys in identifying documents to request during discovery and advise on
    questions to ask during depositions.
  • Identify FDA regulatory deficiencies in the adverse event reporting of a breast cancer drug
    and describe the resulting deficiencies in the drug’s label.
  • For a hip implant, write an expert report describing the company’s non-compliance with FDA labeling requirements and reporting of adverse event information.
  • Write a report describing why the processes establishing the stability of a drug product
    met FDA compliance requirements for marketing.
  • Review the statistical design of a clinical trial intended to compare the effectiveness of two
    drugs. Determine if the study design was manipulated to mask the weakness of one drug
    over the other.
  • Review and find weaknesses in an expert’s report on the adverse event reporting of
    fentanyl. Write a report of findings.
  • Analyze the content of a drug IND submission to identify trade secret content.
  • Explain the complexities of the FDA drug approval process to a jury.

KEY SKILLS, EXPERIENCE & QUALIFICATIONS

  • Former FDA reviewer
  • Write expert reports on safety and FDA compliance of hip implants
  • Skilled in depositions and testimony
  • Vast experience as an auditor of FDA compliance
  • Expert in software development
  • Confirm data integrity
  • Speaker at FDA meetings with drug and medical device companies
  • Critique adverse event reporting
  • Support attorneys in cases involving sulindac, fentanyl, Actos, breast cancer drugs and ADHD drugs
  • Perform statistical analysis
  • Identify, prevent and solve FDA compliance problems for drug and device companies of all sizes
  • Trained over 50,000 people on more than 40 FDA-related technical and compliance topics
  • Write submissions, SOPs, study reports
  • Testify as an FDA expert witness in drug, biologic, and medical device cases

Get in Touch




Sharlin Consulting

Joshua Sharlin, PhD

jsharlin@pipeline.com

 

Cell: 410-231-8900

(Washington, D.C.)

 

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