GMP · GLP · GCP · GDP · GVP
GxP
Compliance
Leaders in Good-Practice Compliance
Across the Product Lifecycle
Leaders in Good-Practice Compliance
Across the Product Lifecycle
GxP is shorthand for the family of good-practice regulations that govern how medical products are made, tested, studied, shipped, and watched: GMP on the manufacturing floor, GLP in the nonclinical laboratory, GCP in the clinic, GDP on the road, and GVP after launch. The disciplines differ, but they share one grammar: if it was not documented, it did not happen — and if it cannot be retrieved, reconstructed, and defended under questioning, documenting it was not enough. We build, audit, and repair GxP systems that hold up when a regulator reads them back to you.
Every GxP discipline reduces to the same demand: show the evidence, and show that it holds together.
Each discipline governs a different room in the same house, answers to a different inspectorate, and breaks in its own characteristic way. Fluency in all five is what makes a compliance program coherent instead of five parallel paper systems.
Can you prove every batch was made exactly the way the license says it was?
Would the study reconstruct from raw data alone, without the people who ran it?
Does the data trail protect both the patient and the endpoint?
Did custody or cold chain ever lapse between the dock and the dose?
Would a real signal in the noise have reached you inside the reporting clock?
In the clinic, GCP is the difference between data you can submit and data you must explain.
No product lives in a single discipline. It is carried through all five in sequence, and the record it accumulates along the way is the product, as far as any regulator is concerned.
The tox package is built under laboratory practice rigorous enough to carry an IND.
Human evidence is generated under clinical practice that protects subjects and endpoints alike.
The process is scaled and every batch released against the story told in the filing.
The batch record extends onto the road: storage, transit, and custody stay in a validated state.
Surveillance watches every dose in the field for the signal the trials were too small to see.
GDP extends the batch record onto the road — every mile is part of the product’s history.
Inside a discipline, ownership is clear. Between disciplines, it usually is not — and the seams are exactly where regulators have learned to look. Four clean audits can still add up to one broken system if nobody audits the handoffs.
Nonclinical data handed to the clinic without an archive that reconstructs. The first-in-human decision rests on studies someone else must now be able to defend.
Trial safety reporting that never gets mapped into post-market surveillance, so the vigilance system starts life blind to what the trials already knew.
Product released perfectly, then stored and shipped outside the conditions the stability data supports. Release is not the end of the record.
Tech transfer between development, CMO, and commercial sites where process knowledge lives in people who do not make the move with it.
The finding that hurts is rarely inside a department. It is between two of them.
Every engagement is led by a senior practitioner who has run the discipline being examined, not observed it. Four ways sponsors put us to work:
Annual internal audit calendars across any or all five disciplines, weighted by product risk and regulatory exposure rather than by habit, with findings written to be actionable.
A mock-inspection-grade read of one discipline or the whole estate, mapped into a prioritized, CAPA-ready remediation plan — and, where needed, the hands to execute it.
A senior quality leader embedded part-time: owning the audit program, chairing quality review, and giving the QMS an experienced signature without a full-time hire.
PAI readiness ahead of an approval decision, or a rapid for-cause investigation when a signal, complaint trend, or supplier failure demands an answer regulators will accept.
Every deviation, audit, and control judged against what a regulator will accept, on the floor and in the record.
GxP judgment is not learned from checklists. Your leads are former inspectors, QA heads, and quality directors who have hosted the inspections your program is being built to survive — and who know the difference between a finding that matters and one that merely fills a report.
GMP, GLP, GCP, GDP, and GVP expertise under one roof, so cross-discipline seams get audited instead of orphaned.
FDA 21 CFR, EudraLex, ICH Q10, WHO, and PIC/S — mapped to how your regulators actually inspect, not just how the guidance reads.
Findings graded the way an inspectorate would grade them, so remediation effort lands on what would actually be cited.
Every observation arrives with a practical path to closure. We are hired to make problems go away, not to catalogue them.
A good-practice program touches every corner of the quality system. These are the services GxP clients reach for most.
For sterile and aseptic operations, the EU GMP Annex 1 contamination control strategy that lives inside the wider GMP system.
Explore Sterility Assurance →The full dress rehearsal: your GxP systems examined the way FDA or EMA would examine them, before it counts.
Explore Mock Inspections →The quality management system that turns five disciplines of obligation into one coherent, operable structure.
Explore QMS →When an audit or inspection finds the gap, the corrective machinery that closes it for good.
Explore CAPA →Tell us which disciplines keep you up at night and where your quality system stands. We’ll match you with a senior GxP lead, with a response within one business day. All inquiries are strictly confidential.
