Valicom offers a wide range of auditing services to the pharma, biotech, device, and diagnostic industries, and to suppliers of those industries.
Internal Audits | External and Supplier Audits | Clinical GCP Audits | Company Representation
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 and services:
Manufacturers of APIs, biologics, and device and diagnostic components, both within and ex-US. We’ve audited facilities that perform organic synthesis, peptide synthesis, sterile fill/finish operations, and component molding and extrusion
Contract Manufacturing Organizations, including those for production of biologics, injectables, solid dosage forms, devices, and diagnostics
Packaging and Labeling operations
Warehousing and distribution 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
Preclinical services, including:
Testing laboratories
Animal facilities
Assistance during Audits of Your Company
We’ve assisted in presenting materials and negotiations during:
Regulatory agency inspections, including FDA and California’s FDB
Audits of companies, including those conducted by suppliers and during acquisitions
Please contact us to learn more how we can customize our services and expertise with GMP, GCP, GLP, HIPAA and GDPR to assist you with your auditing needs. Our audits are comprehensive and cost-effective, and we don’t subcontract auditing services.