Life Sciences

Elevating Regulatory Readiness and Training for Pharmaceutical Professionals

About the Client

An internationally recognised pharmaceutical training and testing company, accredited for its professional services, partnered with MOAT to enhance regulatory and training support for their clients. The organisation provides expertise in GMP and GDP practices, auditing and lead audits, qualified person certifications, and validation services.

The Challenge

Pharmaceutical companies face rigorous regulatory environments requiring ongoing staff development and system readiness. The client sought to:

  • Support clients in achieving FDA inspection readiness.
  • Provide professional development and training on GMP and GDP practices.
  • Identify and address gaps in compliance processes.
  • Reduce the risk of regulatory penalties for their clients.

The Solution

MOAT collaborated with the client to deliver tailored regulatory and training services, including:

Professional Development: Designing and implementing accredited training programmes on GMP, GDP, auditing, and validation.

Pre-Inspection Support: Conducting mock FDA inspections and audits to identify compliance gaps and improve systems.

Regulatory Expertise: Providing insights to strengthen client quality systems and prepare for FDA inspections.

Change Management: Guiding clients through necessary process improvements and staff readiness initiatives.

The Outcome

Enhanced Compliance: Clients achieved improved FDA readiness with strengthened systems and processes.

Professional Growth: Delivered impactful training that empowered staff with up-to-date industry knowledge.

Reduced Risk: Clients minimised compliance gaps, avoiding potential regulatory penalties.

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