With decades of international GMP experience across pharmaceuticals, biotechnology and medical devices, Acennix partners with manufacturers to build sustainable compliance cultures that put patients first.
Over 20 years of proven expertise.
20+ Years Experience
All international GMP Standards
IRCA Certified
Since 2003, Acennix has been the trusted pharmaceutical consulting organisation. Over 20 years of proven expertise delivering real results through deep industry knowledge and practical, outcome-focused solutions.
To accelerate pharmaceutical innovation and patient access through expert consulting services that deliver measurable outcomes. We believe in the power of evidence-based strategies and collaborative partnerships.
Our mission drives everything we do – from the way we approach complex QA and GMP challenges to how we develop market access strategies that truly serve patients and healthcare systems.
We deliver the highest quality consulting services with attention to detail and commitment to excellence.
We focus on delivering measurable outcomes that drive real value for our clients and their patients.
We maintain the highest ethical standards and transparency in all our client relationships and work.
Deep industry knowledge across all dosage forms and regulatory environments, combined with practical experience delivering results.
We are proud to partner with global pharmaceutical and biotech innovators who trust Acennix to deliver lasting results.
Acennix partners with leading pharmaceutical and biotech organisations to deliver strategic GMP and quality compliance consulting solutions that strengthen regulatory alignment, optimise quality systems and enhance operational performance. Our proven expertise enables clients to navigate complex global regulations, mitigate risk and achieve sustainable operational excellence across every stage of the product lifecycle.
Comprehensive validation consultancy ensuring systems, equipment and processes meet global GMP and regulatory expectations. Acennix provides end-to-end validation support including equipment qualification, process & cleaning validation — all aligned with EU GMP and FDA requirements. We help clients design, execute and maintain robust validation frameworks that support inspection readiness and product quality.
Validation Master Plans (VMP) and protocols
Equipment and facility qualification
Cleaning and analytical method validation
Aseptic Process Simulation (media fill)
3-12 months depending on scope and complexity
Tailored GMP and quality compliance training desgined to strenghten organisational capability and culture. Our programmes cover Good Manufacturing Practice (GMP), data integrity, risk management and quality system implementation, providing teams with the skills to maintain audit-ready operations. We translate complex QA and GMP expectations into practical, sustainable practices for teams at every level.
Basic GMP and cleanroom operations
Data Governance
QMM
Investigator Training
Public programs and custom in-house training
Independent auditing and gap-assessments that drive continuous improvement and compliance maturity. Acennix conducts internal, supplier and third-party audits across pharmaceutical and biotech environments, using global GMP frameworks (EU, FDA, PIC/S, WHO). Our objective insights and practical recommendations help clients align operations with international quality standards and sustain long-term compliance.
Self-inspection audits for facilities and processes
Supplier audits and assessments
Due diligence audits
Mock FDA and MHRA regulatory inspections
IRCA certified with ISO 19011 compliance
Strategic project-management expertise supporting quality, validation and compliance initiatives. From facility start-up and technology transfer to remediation and continuous-improvement projects, Acennix ensures deliverables are met efficiently and aligned with global QA and GMP expectations. We provide planning, execution and oversight that integrate seamlessly with your existing quality systems and timelines.
Regulatory compliance and new regulation implementation
Facility expansion and renovation projects
Quality system alignment across multiple sites
Remediation and regulatory compliance resolution
Multi-disciplinary expertise with proven methodologies
A proven methodology that delivers results through strategic planning, expert execution, and measurable outcomes. We combine strategic insight, GMP and QA alignment and practical implementation to ensure sustainable, audit-ready operations worldwide.
Understanding your challenges and objectives
Developing tailored solutions and roadmaps
Implementing with precision and expertise
Delivering measurable outcomes and value
Ready to accelerate your pharmaceutical success? Let's discuss how our expert consulting services can support your objectives and deliver measurable results. E-mail enquiry@acennix.com
Partner with Acennix for trusted pharmaceutical consulting that delivers real results. Since 2003, we've been helping companies achieve quality assurance compliance and operational excellence.