For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Client requires an initial consultation to provide a practical, plain-language overview of EPA GLP requirements and key differences from current GMP framework. Client also needs a focused gap assessment of the analytical chemistry and microbiology laboratories, as well as recommendations and a roadmap to support EPA GLP readiness objectives.

Phase 1: Initial Consultation

• Approximately 10 hours
• Review current laboratory processes and documentation
• Define EPA GLP requirements applicable to the site
• Confirm scope, objectives, and assessment criteria
• Develop a detailed plan for the gap assessment

Phase 2: Formal Gap Assessment

• Approximately 2 days on-site
• Focused on analytical and microbiology laboratories
• Evaluate laboratory controls, procedures, documentation, quality systems, and GLP-specific requirements
• Identify compliance gaps and practical remediation recommendations
• Deliver a prioritized summary of findings and next steps

This phased approach allows requirements to be clearly defined before undertaking a targeted EPA GLP gap assessment.

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