Inspection Readiness

Our GCP experts have experience spanning therapeutic areas and national and international regulations. GCP services include:

• GCP Gap Analysis
• Internal Sponsor Audits
• Investigator Site Audits
• Vendors and Contract Research Organization (CRO) Audits and Management
• Institutional Review Board (IRB) / Institutional Ethics Committee (IEC) Assessments
• Archive Facilities Audits
• Clinical Trial Supplies Storage Facility Audits
• Computer System Validation (CSV)
• Data Center Audits
• Central and Local Laboratories Audits

Our team of expert GLP consultants provide services including:

• Test Facilities
• Studies and Reports
• Central Laboratories for Clinical Trial Samples
• Toxicology Laboratory
• Bioanalytical Facilities
• Analytical Processes

Our GMP services include:

• Manufacturing Site Audits
• Internal Sponsor Audits
• Contract Laboratory Audits
• Records Storage Facility Audits
• Active Pharmaceutical Ingredients (APIs)
• Vendor Qualification
• Quality Management Systems (QMS) (CAPA and Deviation Management)
• Facility and Equipment Assessments
• Quality Agreements Review
• Batch Records Review

We have a strong understanding of PV regulations and guide our clients in applying the requirements to their processes. GVP services include:

• Sponsor's PV Systems
• Business Partners
• Assessment and oversight of PV Service Providers
• Drug Safety Surveillance Activities

We provide CSV auditing services for all computerized systems that fall under GxP. We help our clients identify gaps and provide remedial actions based on Good Automated Manufacturing Practice (GAMP), 21 CFR Part 11 compliance, and other industry guidance. CSV audits review:

• SOPs, WIs, and templates
• Software Development Life Cycle (SDLC) procedures
• Validation Documentation
• Infrastructure and Network Management