Services: Compliance

Cato Research's expert auditors perform a diverse range of audits including cGLP, cGMP, and Quality Systems audits. We also perform independent, third-party audits for compliance with cGCP, an indispensable element to any successful drug discovery and development process.

Audits help avoid costly delays in bringing your product to market and help identify questions and inconsistencies. Cato Research has a record of distinction achieved from many years of audit experience, led by a team of graduates of the ISO 9000 Lead Auditor course and examination.

Our auditors will help you develop an audit action plan that addresses all of your issues. We will also help you implement the plan and meet with investigators in order to reach a consensus on how the regulatory audit will be handled.

At Cato Research, we offer expertise in the following areas:

cGMP Audits

Facilities inspections

Sterile and nonsterile drug products, biologics, drug substance, devices, analytical and microbial laboratories, packaging and labeling, and distributor

Pre-approval preparation inspections

Product monitoring

Regulatory compliance

cGLP Audits

Facilities inspections

Methodology

Scientific integrity, feasibility assessment, application of strategic plan

Regulatory compliance

System inspections

cGCP Audits

Investigator and site audit

Clinical and laboratory facilities, procedures, personnel and resources

Sponsor and contract research organization audits of standard operating procedures; medical, regulatory and nonclinical facilities, training records, and personnel

IRB Audits

Membership, practices, and procedures

Data audits

Subject records, source documents, database, and study methods

SOP Development