GxP
Compliance
An inspection doesn't announce itself. We build the quality systems, audit programs, and inspection readiness posture that make regulatory scrutiny a routine event, not an emergency.
Findings Aren't Random. They Accumulate in Predictable Places.
FDA Warning Letters and EMA statements of non-compliance reveal consistent patterns: quality systems that weren't built to be inspected, CAPA programs that close records without closing root causes, and audit programs that haven't kept pace with operational change. The organizations that perform well under regulatory scrutiny build compliance into operations; they don't retrofit it in the weeks before an inspection window opens.
A finding at one facility affects your full program. Pre-inspection assessment finds the exposure before the inspector does.
Talk to a GxP ExpertGMP to GVP. Every Discipline, Full Depth.
Our GxP practice covers the full spectrum of good practice requirements, from manufacturing facility audits through pharmacovigilance system quality, with practitioners who have managed these programs from both the regulatory agency and industry side.
GMP Auditing & Manufacturing Compliance
Pharmaceutical and biopharmaceutical manufacturing audits under 21 CFR Parts 210 and 211, EU GMP Annex guidelines, WHO GMP standards, and PIC/S guidance. We conduct pre-approval inspection preparation, quality systems assessments, process qualification reviews, annual product reviews, and site readiness evaluations for FDA, EMA, MHRA, and WHO inspections, including biologics and sterile manufacturing environments.
GCP Compliance & Clinical Quality Oversight
Clinical trial compliance programs under ICH E6(R2), 21 CFR Parts 312 and 812, and EMA GCP guidelines. We conduct clinical site qualification audits, investigator site audits, sponsor system audits, clinical vendor and CRO audits, and data audit trail reviews. Our GCP practitioners have experience across Phase I through IV trials and regulatory submissions, including audit preparation for FDA Bioresearch Monitoring (BIMO) inspections.
GLP Compliance & Nonclinical Laboratory Audits
Nonclinical laboratory compliance programs under 21 CFR Part 58 and OECD GLP Principles. We conduct facility audits, study audits, master schedule reviews, and management system assessments for contract research organizations and internal nonclinical laboratories. Our GLP audit programs are designed to pre-empt FDA and OECD Monitoring Authority inspections and to qualify contract laboratories used in IND-enabling study programs.
GDP & Distribution Quality
Distribution quality programs under EU GDP guidelines 2013/C 343/01, WHO GDP guidance, and applicable national frameworks. We design cold chain qualification programs, conduct wholesaler and 3PL distributor audits, develop temperature excursion handling protocols, and build the distribution quality management systems required for qualified person (QP) release and serialization compliance. Includes GDP training programs for distribution network personnel.
GVP & Pharmacovigilance Quality Systems
Pharmacovigilance quality management systems aligned to EMA GVP Modules, ICH E2E, and applicable national reporting requirements. We design and audit PSMF-compliant pharmacovigilance systems, conduct quality reviews of ICSR workflows and signal detection processes, and run audit programs for pharmacovigilance service providers under MAH oversight obligations. SUSAR and PSUR quality audit programs available.
Supplier Qualification & Vendor Audit Programs
Risk-based supplier qualification programs and ongoing vendor audit cycles for contracted manufacturing organizations, API suppliers, laboratory service providers, and critical material suppliers. We build audit program infrastructure (schedules, protocols, vendor risk classifications, and qualification status tracking) aligned to ICH Q10 quality management system requirements and FDA/EMA audit trail expectations for supply chain oversight.
Manufacturing Quality That Holds Up Under Agency Review.
FDA drug manufacturing inspections now include unannounced components for foreign facilities and carry consequences that reach beyond the site: import alerts, consent decrees, and application integrity holds affect the full portfolio of a sponsor whose facility receives a Warning Letter. The standard for avoiding this is not documentation; it is a quality system with genuine operational integration.
We conduct GMP gap assessments against current FDA and EU GMP expectations, design and execute pre-approval inspection preparation programs, and provide qualified manufacturing quality leadership for organizations building out or scaling GMP infrastructure. For facilities that have received 483 observations or Warning Letters, we develop remediation roadmaps that address both the specific findings and the systemic conditions that produced them.
GMP Program Scope
- 21 CFR Parts 210, 211 compliance assessment
- EU GMP Annex 1, 2, 11, 15, 16 audits
- Pre-approval inspection (PAI) preparation
- Manufacturing process qualification review
- Cleaning validation and analytical method review
- Stability program assessment
- Annual product review (APR/PQR) programs
- 483 observation response & remediation
- Warning Letter response and consent decree support
Inspections Reward the Organizations That Treat Them as Routine.
The most effective inspection readiness programs aren't activated in response to a scheduled inspection window; they run continuously as part of operations. Organizations that treat inspection preparation as a distinct, periodic event find themselves scrambling to close gaps that have been accumulating between cycles. Those that build readiness into daily operations find the inspection itself unremarkable.
We design inspection readiness programs calibrated to your specific inspection history, regulatory profile, and facility risk level. For organizations facing an imminent FDA or EMA inspection, we provide intensive pre-inspection preparation: back-room organization, front-room protocols, document room management, subject matter expert briefings, and mock inspection exercises with inspectors experienced in the specific agency and product type being inspected.
Inspection Readiness Program
- Continuous readiness assessment and monitoring
- Mock FDA, EMA, MHRA, WHO inspections
- Back-room and front-room preparation protocols
- Document room organization and retrieval systems
- SME briefing and interview preparation
- Real-time inspection support and response drafting
- Post-inspection 483 response strategy
- CAPA development for inspection observations
- Inspection metrics and readiness dashboards
A CAPA That Closes a Record Without Closing a Root Cause Is a Future Finding.
Regulators review CAPA programs not just for closure rates but for evidence that root causes were genuinely identified and systemic changes implemented. A CAPA backlog filled with records closed on schedule but without substantive remediation is a significant inspection finding in itself, and one that reflects on the quality system as a whole.
We assess CAPA program health across the full lifecycle: effectiveness of root cause analysis methodology, adequacy of corrective action scope relative to the finding, preventive action design for systemic issues, verification of effectiveness before record closure, and trending of CAPA data for signals of recurring quality system weakness. For organizations with Warning Letters or consent decree obligations, we provide the independent CAPA oversight and verification required by FDA remediation agreements.
CAPA Program Assessment
- Root cause analysis methodology review
- CAPA backlog assessment and triage
- Effectiveness check design and verification
- Preventive action scope evaluation
- CAPA trending and signal detection
- Quality system linkage (change control, deviations, complaints)
- SOP and procedure gap assessment
- Warning Letter CAPA response support
- Consent decree CAPA oversight
Every Major Inspection Authority. Every Major Product Type.
GxP expectations are not uniform across agencies, product types, or inspection classification. Our practitioners have direct experience with each agency's current enforcement posture and inspection methodology.
U.S. Drug, Biologic & Device
Pharmaceutical, biopharmaceutical, and medical device facility inspections under 21 CFR frameworks. OAI, VAI, and NAI classification management. BIMO clinical inspections. PAI and NDA/BLA pre-approval inspection preparation.
European GMP, GCP & GVP
EU GMP Annex compliance for pharmaceutical and biologic facilities. MHRA, ANSM, BfArM, and AIFA inspections. EU GVP module compliance and MAH audit obligations. EMA GCP inspections under Clinical Trials Regulation.
International GMP Standards
WHO GMP inspections for prequalification and international tender supply programs. PIC/S GMP for mutual recognition jurisdictions. Health Canada Division 2 GMP compliance. International supply chain qualification.
Clinical Investigation Inspections
Bioresearch Monitoring Program inspections of clinical investigators, sponsors, CROs, IRBs, and nonclinical testing facilities. Full lifecycle preparation from IND-enabling studies through post-approval commitments.
Nonclinical Laboratory Compliance
OECD GLP Principles and national GLP monitoring authority inspections for nonclinical testing facilities. Compliance monitoring programs for contract CROs used in IND-enabling toxicology and pharmacology programs.
Quality Management Systems
Pharmaceutical quality system design and assessment under ICH Q10, ICH Q7 (API), and ISO 9001 frameworks. Quality system integration across development, manufacturing, distribution, and pharmacovigilance functions.
Regulatory Frameworks We Navigate
- 21 CFR Part 210/211
- 21 CFR Part 312/812
- 21 CFR Part 58
- 21 CFR Part 11
- ICH Q7 API GMP
- ICH Q10 PQS
- ICH E6(R2) GCP
- ICH E2E PV
- EU GMP Guide
- EU GMP Annex 1
- EU GMP Annex 11
- EU GDP 2013/C 343/01
- EMA GVP Modules
- OECD GLP Principles
- WHO GMP
- PIC/S GMP
Let's Talk About Your GxP Compliance Posture.
Tell us where you are (upcoming inspection, remediation in progress, building a new quality system, or assessing an acquisition) and we'll bring the right practitioners to the table. All inquiries are confidential.