Assessment and Gap Analysis 

Our structured approach pinpoints areas of risk, inefficiency, and non-compliance, enabling targeted improvements. Gap analysis helps uncover overlooked responsibilities, unclear procedures, and inconsistent practices that may jeopardize inspection outcomes.Through interviews, document reviews, and process walkthroughs, we gain a clear picture of operational readiness across all functional areas.

The goal is not just to pass an inspection, but to embed sustainable compliance into your day-to-day operations. Findings are delivered with prioritized, actionable recommendations to close gaps and strengthen inspection readiness.

Whether you're preparing for your first inspection or enhancing ongoing compliance, our gap analysis provides the clarity and roadmap you need

Development and Implementation of Remediation Plans

 

Effective remediation begins with a clear, prioritized plan to address identified gaps and risks. We work collaboratively to develop tailored remediation strategies that are practical, compliant, and aligned with your organization’s operations. Each remediation plan includes defined actions, responsible owners, timelines, and success criteria to ensure accountability and measurable progress.

 

Our team guides implementation from start to finish, helping to embed changes into workflows and quality systems. We don’t just fix problems—we build sustainable solutions that support long-term inspection readiness and operational excellence.

 

Regular progress tracking and follow-ups ensure remediation efforts stay on course and deliver the intended outcomes. Whether addressing documentation gaps, training deficiencies, or procedural weaknesses, our remediation plans drive real, lasting improvements.  Successful remediation is not about checking boxes—it’s about creating a culture of continuous compliance and improvement

 

 

Training 

 

Our training emphasizes real-world inspection scenarios, mock interviews, and regulator expectations to prepare teams for both announced and unannounced inspections.

  • We train stakeholders across all levels—site staff, study teams, sponsors, and CROs—on how to proactively identify and address inspection risk areas.
  • Our GCP-focused inspection readiness sessions reinforce core regulatory requirements and highlight common inspection findings, ensuring your team knows how to avoid them

  • We help organizations establish a culture of continuous inspection readiness, integrating quality by design (QbD) and compliance into routine operations."

  • "Our sponsor oversight modules empower clinical operations teams to effectively manage and document vendor oversight activities in alignment with ICH E6 (R2) expectations."

  • "With customized mock inspections, document readiness reviews, and communication training, we ensure your team is inspection-ready—not just compliant on paper."

  • "We provide role-specific training that prepares individuals for their unique responsibilities during regulatory inspections, including sponsor representatives, CRAs, and site staff.

 

 

Mock Inspections

 

  • Our mock inspections simulate real regulatory visits, providing your team with hands-on experience and actionable feedback to close compliance gaps before the real thing.

  • We conduct customized mock inspections that reflect the scope, intensity, and documentation requests typical of FDA, EMA, MHRA, or other regulatory authority audits.

  • Our expert-led mock inspections identify process, documentation, and training weaknesses—offering targeted recommendations to mitigate inspection risks.

  • We help organizations assess inspection readiness across all trial stakeholders, including sponsors, CROs, investigators, and site staff.

  • Our mock inspections include detailed debriefs, inspection day coaching, and corrective action planning to ensure your team is fully prepared.

  • We simulate interviews, document reviews, and facility tours to evaluate how effectively your team can present and explain clinical operations under scrutiny.

  • Each mock inspection is designed to assess readiness against current regulatory expectations, GCP standards, and best practices in sponsor oversight.

  • Our services support a culture of ongoing quality and compliance—not just a one-time fix—by providing a structured, educational experience for all involved parties