Inspection Readiness

Health Authority (HA) inspections of clinical trials can take place on short notice, and thorough preparation is essential for a streamlined process that frequently culminates in marketing approval. At Halloran, our team of quality, clinical operations, and regulatory experts possesses a keen insight into the HA's expectations and how to equip your study team with the necessary documentation. This enables productive interactions with inspectors, propelling your company to the next phase of development.

By conducting Inspection Readiness (IR) gap assessments, learn how Halloran can help your company:

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