01
GxP Services
GMP, GCP, GLP audits, CAPA, process validation and regulatory mock inspections for pharma and life sciences.
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Global Assurance. Delivered with Precision.
One Ecosystem. Integrated Assurance.
We partner with our clients as trusted specialists, delivering integrated assurance with confidence and agility — enabling businesses to achieve excellence, build resilience, and prepare for the future.
Sector Expertise
Industries We Serve
Why Organisations Come to Us
Risks impacting you
01
Regulatory Non-Compliance
Failing audits, enforcement actions, warning letters and sanctions — the cost of non-compliance is existential. Regulators are tightening.
02
AI & Digital Governance Gaps
EU GMP Annex 22 is in force. EU AI Act enforcement begins August 2026. FDA has issued AI warning letters. No validated programme means findings.
03
Certification Failure
Failed first-time audits, suspended certificates and lost contracts. Certification bodies are raising the bar and organisations are unprepared.
04
Supply Chain Non-Conformance
Customer requirements unmapped. Supplier audits failing. Approved supplier status revoked. Your supply chain is only as strong as its weakest audit.
05
Fragmented Management Systems
Different teams, different specialists, no integration. Duplication, inconsistency and unsustained certifications. Costs multiply with no added value.
06
Weak Internal Audit Capability
Auditors lack competence or independence. Audits become box-ticking. The organisation goes into external audits unprepared and exposed.
What We Do
Solutions we deliver
02
Purpose Driven Audits
Supplier, internal, social compliance, due diligence and pre-qualification audits across 12+ sectors globally.
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03
Management Certification
ISO 9001, 14001, 45001, 27001, IATF 16949, AS9100, IRIS, TL 9000, IMS and more — expert-led certification and compliance services.
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04
Cyber & Digital
SOC 1/2, CMMI, Data Integrity, CSV, Cyber Threat Management and Data Protection services.
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05
Training Programmes
Lead Auditor, Internal Auditor, Implementor and Awareness training — internationally recognised courses across all major standards.
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Full Capability
End-to-End Compliance Ecosystem
01 — GxP
Pharmaceutical & Life Sciences
- GxP Assurance & Quality System Design
- Equipment Qualification (IQ/OQ/PQ)
- Process & Cleaning Validation
- CAPA & Deviation Management
GxP Audits
- GVP · GCP · GLP · GMP · GDP
- EXCIPACT · Mock Inspections
- Due Diligence & Supplier Audits
02 — Certification
Management System Certification
- ISO 9001 · ISO 14001 · ISO 45001
- ISO 27001 · ISO 27701 · ISO 42001
- ISO 13485 · ISO 22000 · ISO 22301
- IATF 16949 · AS/EN 9100
- IRIS / ISO TS 22163 · TL 9000
- ISO 37001 · Integrated Systems
Product Certification
- CE Marking · BIS Certification
03 — Digital & ESG
Cyber, Digital & Sustainability
- Computer Systems Validation (CSV)
- Data Integrity & Governance
- Cyber Threat & Vulnerability Mgmt
- SOC 1 / SOC 2 / SOC Cyber
- CMMI Appraisal Services
ESG & Sustainability
- ESG Due Diligence & Assurance
- Supply Chain Sustainability
- ESG Reporting Frameworks
Standards We Cover
40+ International Standards
ISO 9001
Quality Management
ISO 14001
Environmental Mgmt
ISO 45001
Health & Safety
ISO 27001
Info Security
ISO 13485
Medical Devices
ISO 42001
AI Management
IATF 16949
Automotive Quality
AS 9100
Aerospace Quality
ISO 22000
Food Safety
ISO 22301
Business Continuity
ISO 27701
Privacy Information
ISO 37001
Anti-Bribery
Our Story
Built on Expertise.
Driven by Purpose.
AjaCertX is a global assurance organisation. We combine deep technical expertise with a genuine commitment to helping organisations build resilient, compliant and trustworthy systems — across quality, safety, environment, security and sustainability.
Our multidisciplinary teams serve clients across 12 industry sectors — from pharmaceutical giants to technology startups — with the same rigour and results-orientation.
Why AjaCertX
01
Certification Expertise
Deep expertise across ISO management system standards, sector-specific schemes and specialist frameworks — delivering rigorous, credible certification services.
02
Industry Specialists
Our auditors and specialists are domain experts — not generalists — with decades of sector-specific experience.
03
One Ecosystem
Certification, audit, training, cyber and ESG — all under one roof, fully integrated.
04
Global Delivery
Serving clients across multiple continents with specialists experienced in international regulatory environments.
"To be the most trusted partner in building organisations that are safe, ethical, sustainable and excellent — one standard at a time."
AjaCertX Purpose Statement
Client Voices
Trusted by Leading Organisations
AjaCertX's GMP audit team brought an exceptional level of rigour and practical understanding to our facility review. Their mock inspection prepared us thoroughly for our regulatory submission.
Pharmaceutical Manufacturer, India
We achieved IATF 16949 certification on our first attempt. The AjaCertX team's structured approach and deep automotive knowledge made all the difference.
Tier-1 Automotive Supplier, Germany
The SOC 2 readiness assessment was handled professionally and efficiently. Our clients now have the confidence that our data practices meet the highest international standards.
SaaS Platform Provider, United Kingdom
Join Our Team
Build Your Career at AjaCertX
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How to Join Us
Discover our recruitment process and what we look for in candidates.
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Job Search
Browse current vacancies globally in certification, audit, training and cyber.
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Life at AjaCertX
Flexible working, global teams, continuous learning and a culture of excellence.
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What You Can Do
Lead audits, shape global standards and build deep expertise across every sector.
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Get in Touch
Contact Us
Get in Touch
We're Here to Help
Whether you need a certification, an audit, expert guidance or want to understand how we can support your organisation — our specialists are ready to assist.
Send Us a Message
We'll respond within one business day.
Certificate Verification
Verify Any AjaCertX Certificate
Every certificate issued by AjaCertX — whether a management system certification for an organisation or a training certificate for an individual — is registered in our global registry and can be independently verified in seconds.
Enter a certificate number to confirm its validity, view the certified organisation or delegate name, check the scope of certification and see the issue and expiry dates.
What the Registry Shows
For ISO Certifications
Certified organisation name · Standard · Scope of certification · Issue & expiry dates · Current status
For Training Certificates
Delegate name · Programme completed · Issue & expiry dates · Validity status
Real-Time Status
Valid · Expired · Revoked — with reason where applicable. Results printable as PDF.
Free Resources
AI Compliance Whitepapers
Practical guides for Quality, CSV and Regulatory teams. Download free — no account required.
Whitepaper 01
📄
FDA AI Warning Letter Analysis 2024–2025
Four FDA AI enforcement actions analysed. What every pharma QA team must implement now.
Partner With Us
Build Compliance Solutions Together
Partner with AjaCertX to build scalable, high-trust compliance and certification solutions across industries. We work with assurance firms, technology providers, training organisations and sector specialists to deliver integrated assurance programmes for shared clients.
Whether you are looking to expand your service offering, refer clients, co-deliver projects or build a formal partnership agreement — we welcome the conversation.
Assurance Partners
Co-deliver compliance programmes alongside your existing assurance practice.
Technology Partners
Integrate AjaCertX assurance services into GRC platforms, quality management systems and compliance tools.
Training Partners
Deliver AjaCertX-aligned training programmes and awareness content to your client base or workforce.
Referral Partners
Refer clients seeking certification, audit or compliance services and we handle the rest.
Regulatory Urgency
Two Regulatory Clocks Are Running Simultaneously
EU GMP Annex 22 on AI is now in force. EU AI Act penalties for High Risk AI systems begin August 2026. Pharma AI — including clinical decision support, batch release algorithms, visual inspection systems and diagnostic AI — is classified as High Risk under the EU AI Act.
A single integrated gap assessment covers both obligations simultaneously — understanding your exposure under Annex 22, GAMP 5 AI Guide and EU AI Act in one 10-day engagement.
€30M
Max EU AI Act Fine
Or 6% of global annual turnover — whichever is higher
Aug '26
EU AI Act Enforcement
High Risk AI systems must be compliant before this date
Now
Annex 22 In Force
EU GMP Annex 22 AI obligations apply to all EU facilities
10
Days to Clarity
Full gap assessment covering both Annex 22 and EU AI Act
Ready to Set the Standard?
Join organisations worldwide that trust AjaCertX for integrated compliance and assurance solutions.