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Inspection Readiness

How we help with Inspection Readiness

A Health Authority (HA) inspection of a clinical trial can occur at any time, and preparation is critical to an efficient inspection that often leads to marketing approval. At Halloran, our quality, clinical operations, and regulatory experts understand exactly what the HA is looking for and how to prepare your study team including supportive documentation, so that inspector interactions bring your company to the next stage.

We use a seven-step Inspection Readiness (IR) process. By conducting an Inspection Readiness (IR) gap assessment, we can help you:

  • Establish objectives & standards
  • Review documents and conduct Subject Matter Experts (SME) interviews
  • Collate and categorize findings
  • Prioritize gaps, make recommendations based on risk criteria, and create an IR plan
  • Empower your teams to take ownership and remediate IR gap assessment findings

Halloran facilitates virtual or on-site inspection and audit readiness engagements, helping to prepare our clients for anticipated regulatory inspections (FDA, EMA, MHRA, PDMA, CFDA), diligence by investors, or potential partner evaluations. These engagements include inspection readiness preparedness, mock inspections and audits, storyboard preparation, behavioral interview training, and coaching. Halloran also leads clients through immediate remediation by authoring responses including strategies for remediation and developing corrective and preventative action plans (CAPA).


  • This article is based on opinions and perceptions from the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to our contributors: April Purcell (Specialist) and Michelle Peter (Senior Specialist). The team sat down with Gail Winslow, Head of Marketing, after the conference to share their experiences.   From start to finish, several […]

  • Watch The Quality Equation: Four Essential Components to Enable Drug Development Success In the dynamic landscape of clinical trials, achieving quality excellence is paramount. To do so, it is crucial to identify and focus on the most significant risks and maintain a risk-based mindset throughout the trial’s lifecycle. This is not merely an important consideration; […]

  • Watch Halloran’s Inspection Readiness Webinar Here A Health Authority inspection of a clinical trial can occur at any point during a product’s lifecycle, making adequate preparation essential for a successful inspection and eventual market approval. Unfortunately, sponsors often begin preparing for inspections only when a critical milestone, such as a Biologics License Application (BLA) or […]