GxP Services and Auditing

Regulatory compliance consulting for life sciences organizations

Leverage reliable expertise for supplemental capacity to achieve reliable quality systems and ensure your operations won’t compromise compliance.

Our team applies decades of collective experience both domestically and internationally for start-ups, virtual companies, and established organizations alike. Between GCP, GLP, GCLP, and GMP standards, we offer consulting services spanning every phase and scale of life sciences operations. Working with us guarantees a collaborative partnership suited to your unique business needs, timelines, and risks.

How we support your GxP compliance:

Navigate evolving global regulatory requirements with confidence
Strengthen quality systems without overburdening operations
Maintain sponsor oversight in outsourced and hybrid operating models
Prepare for inspections, audits, and critical regulatory milestones
Address gaps, risks, and findings with efficient, right-sized solutions

Comprehensive GxP services

Audits

Enlist our independent assessments and third-party audits designed to strengthen oversight and identify risk across your quality systems.

Capabilities include:

Third-party and supplier audits
Supplier selection audits
Benchmarking and gap analysis
Regulatory inspection readiness
Critical phase and pre-approval inspections

Good Manufacturing Practice (cGMP)

Whether you need help addressing a backlog or remediating audit or 483 observations, we help resolve outstanding issues. Our GMP consulting supports compliant manufacturing and quality operations under 21 CFR and ICH guidance with services including:

Quality system assessments
Risk assessments
Development of right-sized compliance programs
Compliance training and CAPA programs
Audit and inspection remediation
Testing data and batch record review
Environmental monitoring programs
Complete QA department function
Continuous improvement of quality systems

Good Laboratory Practice (GLP)

Our support includes establishing and maintaining compliant non-clinical laboratory operations, ensuring oversight and data integrity across study planning, execution, and archiving.

21 CFR Part 58 compliance for non-clinical laboratory studies
Quality assurance unit (QAU) and test facilities management (TFM) consulting

Good Clinical Laboratory Practice (GCLP)

Integrate quality principles of GLP with the relevant elements of GCP to ensure the quality, integrity, and reliability of human clinical trial analysis data collected.

21 CFR Part 58
42 CFR Part 493
College of American Pathologist (CAP)
International Conference of Harmonization (ICH)
World Health Organization (WHO)
International Organization for Standardization (ISO) 15189

Good Clinical Practice (GCP)

We offer guidance to support ethical conduct, subject safety, and data integrity throughout clinical trials, including sponsor oversight of CROs and vendors.

International Conference of Harmonization (ICH) E6(R3)
21 CFR Parts 50, 54, 56, and 312

Validation Services

Comprehensive validation expertise to support ongoing compliance across facilities, equipment, systems, and processes, from early-stage operations to global manufacturing networks.

Validation support includes: