Compliance

In today's complex and ever changing regulatory environment, compliance with regulatory body requirements and regulations are strategic keys to the success of any Life Sciences company. Preventing and resolving compliance issues are at the heart of EG Life Sciences Consultants' experience and expertise.


 
Third-party GMP & GLP Compliance Auditing

Complete quality system audits to demonstrate compliance to applicable regulations and to satisfy internal procedural requirements.

 
GAP Assessments

Performance of reviews to identify missing procedural elements and systemic weaknesses.

 
Mock FDA/Notified Body Audits

Perform activities to simulate audit situations and questioning to prepare organizations for the real thing.

 
Due Diligence Compliance Inspections, Audits & Assistance

Review of systems and compliance level of suppliers, partners, and potential acquisitions.

 
FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation

Lead and assist in efforts to resolve regulatory body observations, findings and issues that have resulted in a negative business climate.