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.

GMP Compliance

  • Quality System and Quality Unit organizational assessment

  • Corporate GMP compliance governance and risk assessment

  • Mock GMP and Preapproval inspections

  • Assistance with deviation investigations

  • Application of GMP to new technologies

  • Experienced in small molecule and biologic environments including biotech, blood and blood products and some tissue technologies

  • Experienced in teaching GMP principles to the senior executive level

GCP Compliance

  • Highly experiened in GCP as well as GMP

  • Medically knowledgeable

  • GCP Quality System and QA Organization assessment

  • Mock Sponsor inspections

  • Assistance with CRO selection and qualification

  • 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

Pharmacovigilance

  • Mock FDA postmarketing pharmacovigilance inspections

  • 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

    • Anticipated FDA enforcement actions

    • Negotiation of consent decree terms relating to the role of the Expert and the Auditor

    • Internal investigations of whistleblower complaints, qui tam prevention

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

  • Expert opinions and depositions in certain matters - please contact us to discuss specific needs you may have

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.