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Our Expertise

Our commitment to you is that we will accept only engagements where we firmly believe we can be of value to you.  If your need is outside our core competency we will advise you of any limitations, and if necessary, assist you to find an appropriate advisor.  Our network of colleagues includes constultants with a wide array of capabilities. We are also familiar with many outstanding FDA-specialty law firms we can suggest if your need is for legal help.

NOTE:  We are no longer accepting work outside the U.S. (except Canada).  We also no longer perform GMP facility audits, mock inspections, mock preapproval inspections or other site audits.  We are happy to recommend others in our network if you seek such assistance.

GMP Compliance

  • Quality System and Quality Unit organizational assessment

  • Corporate GMP compliance governance and risk assessment

  • GMP training

  • Assistance with deviation investigations

  • Experienced in teaching GMP principles to the senior executive level

GCP Compliance

  • Highly experiened in GCP as well as GMP

  • Training

  • GCP Quality System and QA Organization assessment

  • Assistance to sites with FDA inspection difficulties

Inspection Readiness and Response

  • Training in FDA inspection methodology, what to expect, effective interviewing skills

  • Evaluation of inspection management logistics

  • Assistance with post-inspection correspondence and meetings

  • Explanation of FDA enforcement options and risks the company may face post-inspection

  • Highly experienced in providing help to legal counsel in high risk or sensitive issues arising from inspection findings


  • Training

  • PADE Inspection readiness training

  • Pharmacovigilance/REMS compliance assessments

  • Integration of pharmacovigilance and technical complaint management systems


Support for Legal Counsel

  • Over 20 years experience providing adjunct services to legal counsel (external and in house) on sensitive or privileged matters

    • Experienced expert witness, depositions, arbitration and live court testimony

    • Support to legal counsel in regulatory requirements, GMP, GCP

    • Anticipated FDA enforcement actions

    • Negotiation of consent decree terms 

    • Internal investigations of whistleblower complaints, qui tam prevention

    • Regulatory risk due diligence in product, site or company acquisitions

Other Health Regulatory Venues

  • Though our expertise is primarily FDA related, we have experience with other venues' requirements as well, particularly EMA and Health Canada.  If your need is not FDA related, please contact us to discuss details.  We only accept matters in which we have the relevant expertise, but will gladly recommend trusted collegues if we feel that will be the best course for you.


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