Auditing

Courant offers a wide range of auditing services to the pharma, biotech, device, and diagnostic industries, and to suppliers of those industries.

Internal Audits

Gap analysis, to determine your extent of compliance. We can combine a gap analysis with a comprehensive risk assessment to determine your current risks of non-compliance and provide a pathway to compliance that is prioritized by risk.

Routine periodic audits of quality systems.

External and Supplier Audits

For supplier qualification and due-diligence purposes, we’ve audited the following types of operations:

Manufacturers of APIs, biologics, and device and diagnostic components, both within and ex-US
Contract Manufacturing Organizations, including those for production of biologics, injectables, solid dosage forms, devices, and diagnostics
Packaging operations
Labeling operations
Warehousing and distribution operations
Sterilization operations
Analytical laboratories that perform:
Material, product, and component testing
Stability studies
Nonclinical GLP and non-GLP testing
Environmental testing
Computerized systems, including suppliers of:
Software for devices
Cloud-based applications (SaaS)
Hosting services, including datacenters, for GxP and HIPAA compliance
Clinical trial management systems, including EDC
Quality system software, including QMS and LIMS
Laboratory software, such as LIMS and networked chromatography applications

Assistance during Audits of Your Company

We've assisted in presenting materials and negotiations during: Regulatory agency inspections, including FDA and State audits of companies, including those conducted by suppliers and during acquisitions.

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