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Consulting
cGMP compliance, quality-system design, process optimisation and validation support for pharmaceutical and life-science organisations.
Consulting servicesDelivering Regulatory Excellence
Consulting, auditing and GMP training for pharmaceutical, biopharmaceutical and medical-device manufacturers preparing for regulated markets.
Three ways we work with you
Trillyum’s quality and compliance team supports clients across GMP, GCP, GLP and other GxP frameworks.
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Auditing
Independent GMP, GDP, GLP, GCP and GVP audits of facilities, systems and suppliers, reported with risk-graded findings.
Auditing services03
GMP Training
Practical, role-specific training delivered on site, from new-hire induction to pharmaceutical quality systems and ICH Q10.
Training programmesWho we help
Organisations that must demonstrate GxP compliance to regulators, customers and partners.
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Pharmaceutical manufacturers
Finished-dose and API sites supplying domestic and export markets.
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Biopharmaceutical companies
Development and manufacturing organisations building or maturing their quality systems.
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Medical-device manufacturers
Companies aligning quality systems and documentation with regulatory expectations.
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Suppliers and contract partners
API, excipient, packaging and service providers that need to meet customer GMP and GDP requirements.
Inspection readiness
From gap analysis to a confident inspection
Trillyum assesses compliance level with a structured gap-analysis approach, helps implement CAPA and prepares sites for inspection by agencies including USFDA, MHRA, MFDS and EDQM.
Assess the gaps
A third-party gap analysis using our compliance-level assessment tool shows where the site stands against the applicable GMP framework, graded by risk.
Facility and system auditsImplement CAPA
Findings become a prioritised corrective and preventive action plan with owners, timelines and verification, so remediation is evidenced rather than assumed.
Quality-system solutionsRehearse the inspection
Mock inspections in the style of the expected authority test documents, systems and people, and coaching prepares subject-matter experts for the front room.
Inspection preparednessSustain compliance
Training, self-inspection and management review keep the system effective after the inspection closes.
GMP trainingOur GMP services
Quality-system solutions, audits, validation, inspection readiness, supplier qualification and more.
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GMP Services
Quality Management System solutions
Design, implement and strengthen a pharmaceutical quality system that meets regulatory expectations and works for the people who run it.
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Quality Risk Management
Practical quality risk management that identifies, assesses and controls risks to product quality and patient safety.
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On-site training, including new hires
Role-specific GMP training delivered at your facility, with induction programmes for new starters.
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Auditing
Facility and system audits
Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.
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Consulting
Project management
Planning and coordination for GMP-related projects, from quality-system upgrades to remediation programmes.
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Facility design and validation
GMP input to facility design, and qualification and validation support for new and modified facilities, utilities and equipment.
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Regulatory inspection preparedness
Mock inspections, gap analysis and coaching so your site and your people are ready for USFDA, MHRA, MFDS, EDQM and other regulatory inspections.
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Supplier auditing and qualification
Audits and qualification programmes for API, excipient, packaging and service suppliers across your supply chain.
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Process review and improvement
Structured review of production, laboratory and quality processes to remove bottlenecks and reduce compliance risk.
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Operational excellence
Lean principles, performance measurement and process optimisation applied within a GMP environment.
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Due diligence
Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.
Learn moreCore values we choose to live by
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Customer focus
We deliver on our commitments and promises, always working with our clients to build long-term partnerships and being the company that they can trust.
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Collaboration
We value the spirit of positivity and teamwork in achieving common goals, and encourage everyone to draw from and contribute to our pool of knowledge, for the benefit of all.
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Communication
We strive to maintain pathways for clear and concise communication, ensuring that everyone has an opportunity to be heard and their opinion is valued.
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Integrity
We are committed to being honest and ethical in everything we do, and make ourselves accountable for all our successes and failures.
Insights
Regulatory Update
New PIC/S documents for GDP inspectors came into force on 1 February 2023, and the MHRA published the 5th edition of its Green Guide for pharmaceutical distributors.
Frequently asked questions
Common questions about GMP consulting and pharmaceutical audits.
Q1How can a GMP consulting firm help my organisation?
A GMP consulting firm provides expert guidance and support to help your organisation achieve and maintain GMP compliance: assessing current processes, identifying gaps, developing robust quality systems, implementing best practices and preparing for regulatory inspections.
Q2What services does a GMP consulting firm offer?
Typical services include GMP audits, gap analysis, documentation and record management, quality-system development and implementation, training programmes, risk assessment, validation support and regulatory-compliance assistance.
Q3How long does it take to achieve GMP compliance?
It depends on the current state of your processes, systems and resources, and can range from several months to a year or more. A detailed assessment gives a realistic timeline for your specific situation.
Q4How do I choose the right GMP consulting firm?
Consider experience, industry reputation, expertise in your specific sector, the range of services offered and the firm’s ability to tailor solutions to your organisation’s needs and challenges.
Tell us about your site and the markets you supply.
We will suggest a scope and next steps, with no obligation.