(GLP and GMP Audits)

Millions of dollars are invested in the research and development of new drug products; investments that are at risk if you are faced with costly delays.

Many companies subcontracting most or all of their nonclinical studies and GMP manufacture often do not have the in-house resources to ensure the integrity of the work.

Strategic auditing and scientific monitoring are essential to prevent:

• Repeating studies
• Unnecessary delays
• Clinical holds
• Additional costs

Ashuren provides the following services to biotech, pharmaceutical and medical device companies:

• 21 CFR 58, OECD GLP requirements for the testing of chemicals, and US, Canadian, ICH and PIC/S requirements for GMPs
• Pre-placement and study audits of contract research facilities
• Monitor nonclinical study initiation and progress
• Assist in the development of a compliance program
• Review non-clinical reports and protocols to ensure GLP compliance
• Assist sponsors in due diligence activities
• GMP audits for clinical trial materials (API and fill/finish facilities)

Ashuren protects your investment.