Clinical & PV Compliance

Your circumstances, problems, and challenges are completely unique.

So are our solutions.

FHA brings Peace-Of-Mind Partnership to a full range of Clinical & PV Compliance Services that range from performing “diagnostic” reviews of PV systems or Clinical Research programs to providing input on development and resolution of corrective and preventive action plans to full auditing.

The confidence you experience comes from partnering with our team of accomplished consultants who are among the most experienced, qualified and successful experts anywhere in life sciences.

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Clinical Research and Pharmacovigilance activities are critical to ensuring patient safety and understanding of product benefits and risks. That’s why FHA conducts all related activities within “systems” that are highly controlled and regulated. Our team of experts is both highly experienced and well versed in the global regulatory requirements for each of these areas, working closely with clients to build and to verify the robustness of compliant systems.

  • Designing a risk-based and robust audit program that meets expectations of global health authorities (including European GVP Modules I and IV)
  • Performing audits of PV systems or Clinical Research programs to ensure compliance with Good Pharmacovigilance Practices (GVP) or Good Clinical Practices (GCP)
  • Performing a PV system or Clinical Program “diagnostic” review to identify gaps in the system that are likely to result in negative inspection findings
  • Assisting with development and execution of robust action plans to close gaps, including documentation to support plans in the event of an inspection
  • Preparing a list of likely inspection topics to be reviewed
  • Supporting clients at the time of inspection by managing the inspection operation, or “control room”

Inspection Preparation:

  • Working with client process owners and/or subject matter experts to determine challenging areas within topics of interest
  • Developing appropriate responses to questions likely to be asked or areas to be probed
  • Performing mock inspection interviews to prepare the client team to respond to a likely inspection scenario

Post-Inspection Preparation:

  • Assist clients with review and understanding of inspection reports, gaining appropriate stakeholder approval, and assigning owners to topics
  • Assist clients with review and understanding of inspection reports and in assigning owners to topics (with appropriate stakeholder buy-in)
  • Support development of effective corrective and preventive action plans (CAPA) that will satisfy both business and regulatory expectations
  • Support action planning around CAPA and execution of plans
  • Conduct evidence review to ensure CAPA related activities have been completed
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