CRSC offers auditing services customized to your specific needs in order to ensure compliance with global project protocols, regulations, guidance documents, procedures, and industry standards.

Our global audit services cover all "good practice" (GxP) areas, which include, but are not limited to:

Internal Audits

Gap assessments
In-Process project
Clinical Trials – all phases
Process improvement

Investigator Site Audits

Sponsor initiated studies
Investigator initiated studies
Phase 1 units

Mock Inspections 

United States Food and Drug Administration (US FDA)
Food and Drug Administration Thai (Thailand FDA)
Health Canada (HC)
European Medicines Agency (EMA)
National Medical Products Administration (NMPA)
Medicines and Healthcare products Regulatory Agency (MHRA)
Pharmaceuticals and Medical Devices Agency (PMDA)
Therapeutic Goods Administration (TGA)
Ministry of Food and Drug Safety of the Republic of Korea (MFDS)

Vendor/Supplier Audits

Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Clinical Laboratory Practice (GCLP)
Good Manufacturing Practice (GMP)
Good Distribution Practices (GDP)
Good Pharmacovigilance Practice (GVP)

Due Diligence Audits

Audit Process Overview

Why choose CRSC?

Knowledge and Experience - CRSC auditors bring specialized expertise in a wide range of GxP areas, including former US FDA Investigators, certified auditors, and/or industry experts with in-depth regulatory knowledge and experience.
Global Footprint - The CRSC team of auditors are equipped with diverse language skills and cultural competence, ensuring seamless communication for audit scheduling, execution, and finalization for any actions needed across international locations.
Speed of Implementation - CRSC auditors can start working on your project right away. This speed of service is vital to implementing robust remediation plans, and ensuring that progress aligns with agreed timelines.

Contact CRSC to get started