GxP & Life Science Services
GxP Programme Design & Implementation
Comprehensive GxP quality programmes for pharmaceutical, biotech, medical device and clinical organisations — covering GMP, GCP, GLP, GDP and GVP obligations.
End-to-end GxP quality management system design covering quality manual, SOPs, batch records, deviation management and CAPA — aligned to ICH Q10 and regulatory expectations.
Get Proposal →GMP compliance programme covering facility qualification, equipment validation, process validation, cleaning validation and GMP documentation systems.
Get Proposal →GDP compliance programme for pharmaceutical distributors and logistics providers — covering temperature control, storage conditions, returns and recall management.
Get Proposal →GCP compliance support for clinical research organisations, sponsors and site management organisations — covering ICH E6(R2) requirements and regulatory inspection readiness.
Get Proposal →GLP compliance programme for non-clinical safety study facilities — covering OECD GLP principles, study director obligations and quality assurance programme design.
Get Proposal →GVP audit services for Marketing Authorisation Holders (MAH), Contract Research Organisations (CRO), affiliate companies and partner service providers handling pharmacovigilance obligations — covering adverse event reporting systems, signal detection processes, risk management plans, pharmacovigilance system master files and regulatory compliance across EMA GVP Module requirements.
Get Proposal →GxP Audits & Inspection Readiness
Independent GxP audits and regulatory inspection readiness programmes — preparing your organisation for FDA, EMA, MHRA and TGA assessments.
Independent GMP and GDP compliance audits identifying gaps against regulatory expectations — with prioritised corrective action plans and remediation support.
Get Proposal →Realistic mock inspections simulating FDA 483, EMA and MHRA inspection approaches — preparing your team and systems for regulatory scrutiny.
Get Proposal →GxP supplier audits of contract manufacturers, laboratories and distributors — verifying compliance with your quality agreement and regulatory requirements.
Get Proposal →Comprehensive internal GxP system audits covering all quality system elements — providing independent assurance of compliance before external inspection.
Get Proposal →Structured inspection readiness programme covering front room/back room preparation, SME coaching, document management and response strategy.
Get Proposal →EXCiPACT qualification audits of excipient manufacturers and distributors — supporting pharmaceutical GMP excipient obligations.
Get Proposal →CAPA & Deviation Management
Structured CAPA and deviation management programmes — from investigation through to effectiveness verification and regulatory submission support.
End-to-end CAPA programme design covering investigation methodology, root cause analysis, action planning, verification and trending.
Get Proposal →Hands-on deviation, out-of-specification and out-of-trend investigation support — covering root cause analysis, impact assessment and regulatory reporting.
Get Proposal →Change control programme design and management covering planned and unplanned changes, regulatory impact assessment and implementation verification.
Get Proposal →FDA 483 observation response and Warning Letter remediation support — building credible, evidence-based corrective action plans accepted by regulators.
Get Proposal →Why Organisations Choose AjaCertX for GxP
We don't just achieve regulatory compliance — we build GxP systems that work, satisfy regulators and give your organisation the confidence to grow.
Deep regulatory expertise across FDA, EMA, MHRA and TGA — we understand what regulators look for and how to build systems that satisfy them.
Pharma, biotech, medical devices, CRO and CDMO — we bring sector-specific GxP expertise aligned to your product type and regulatory pathway.
We transfer knowledge and build internal competence — equipping your team to own GxP systems and respond confidently to regulatory scrutiny.
Regulatory submissions, product launches and inspection windows demand precision. We design and deliver programmes that meet your critical timelines.
How AjaCertX Works With You
A structured engagement methodology — from initial assessment through to ongoing governance and continual improvement.
We assess your current GxP compliance posture against FDA, EMA, MHRA and TGA expectations — identifying all gaps with a prioritised corrective action plan.
End-to-end GxP quality programme design covering SOPs, batch records, deviation management, CAPA and change control — aligned to ICH Q10.
GAMP 5 aligned CSV and AI validation programmes ensuring all GxP computerised systems meet regulatory requirements and are fit for intended use.
Realistic mock inspections simulating FDA, EMA and MHRA inspection approaches — preparing your team, systems and documentation for regulatory scrutiny.
GxP awareness, GAMP 5, data integrity and regulatory expectations training — equipping your people to own compliance independently.
Ongoing CAPA management, deviation tracking, management reviews and regulatory change monitoring — sustaining GxP compliance long-term.
Knowledge For Your Team
Analysis of recent FDA warning letters related to AI systems, data integrity and GxP compliance failures.
Read More →A practical guide to GMP inspection preparation — covering documentation, front room management and CAPA responses.
Read More →How to design a CAPA programme that satisfies FDA, EMA and MHRA expectations — and actually prevents recurrence.
Read More →Our GxP specialists walk through FDA inspection approaches, common 483 observations and how to prepare your team.
Read More →