Simplifying the Complexities of Auditing.

Partner with us for comprehensive quality auditing solutions for process, equipment, and computer systems.

Ensure compliance and operational excellence with trusted experts in Dublin and beyond.

Expertise

Integrity

Excellence

Delivering Unmatched Value in GxP Auditing

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We Are Unique...

At Niche Quality , we pride ourselves on decades of excellence in delivering world-class GxP auditing services. Our team comprises seasoned professionals with extensive expertise in GMP and GDP audits, making us a trusted partner for global organisations seeking precision and reliability in their compliance efforts.

With our proven methodologies and experienced team, we make audits seamless and efficient.

Whether it’s a routine inspection, a supplier audit, or a bespoke assessment of your operations, Niche Quality takes the complexity out of compliance, empowering you to focus on delivering excellence in your business.

Tailored Solutions for Unique Needs:

We understand that every business is distinct, and that’s why we take a tailored approach to auditing. By aligning each project with your specific requirements, we ensure outcomes that deliver both compliance and confidence.

Unmatched Value in GxP Auditing with Industry-Specific Experts:

Each auditor is carefully selected for their proficiency in your sector, ensuring in-depth knowledge and accuracy in every assessment.

Bespoke Audit Programmes:

Beyond standard solutions, we design audits tailored to your unique goals, addressing even the most specialised needs.

End-to-End Support:

Our services extend far beyond the audit itself. From CAPA reviews to ongoing consultation, we support your compliance journey at every step.

Commitment to Quality:

We don’t just meet compliance standards; we set benchmarks. Our rigorous processes ensure your operations consistently achieve and maintain exceptional quality.

OUR OFFER...

Internal Auditing

Our specialised internal auditing services provide a thorough examination of your organisation’s quality management systems, processes, and facilities.

We identify gaps, propose improvements, and ensure compliance with GMP and GDP standards.

Supplier & Vendor Audit

We assess new and existing suppliers, evaluating their capabilities to meet your quality and production standards.

Our audits include on-site and virtual evaluations to ensure reliable partnerships and mitigate risks.

Quality Control Audits

Our quality control audits are designed to review critical areas such as manufacturing processes, laboratory procedures, and storage systems.

We focus on compliance, cleanliness, and capacity to meet stringent regulatory requirements.

Periodic Audit Risk Assessment

We help you maintain robust audit programs by performing periodic risk assessments.

These evaluations determine when and where to conduct audits, prioritising areas that pose the highest risk to compliance.

CAPA Follow-up and Recommendations

Post-audit, we don’t just stop at delivering a report.

We follow up to review Corrective and Preventive Actions (CAPA) and provide actionable recommendations to solidify compliance.

Bespoke Audit Solutions

Need an audit tailored to your unique needs?

From assessing technology transfers to evaluating site readiness for specific regulatory standards, our bespoke solutions are built around your requirements.

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STILL NOT SURE?

Frequently Asked Questions

We understand that navigating regulatory requirements and compliance can be complex and challenging. That’s why we’ve compiled this FAQ section to address common questions and provide clarity about our services. Whether you’re exploring Regulatory Affairs, Project Management, or Product Registration, you’ll find answers to help you make informed decisions and achieve your business goals. If you have additional questions, feel free to reach out to our team for personalized support.

What is GxP, and why is it important for audits?

GxP stands for "Good Practice" guidelines and regulations, including GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and GCP (Good Clinical Practice). Adherence to GxP ensures your processes meet regulatory requirements and deliver safe, high-quality products.

What types of audits does Niche Quality provide?

We offer a range of audits, including internal auditing services, supplier/vendor audits, quality control audits, and bespoke audit solutions tailored to your specific needs. Our services also cover periodic audit risk assessments and CAPA follow-ups.

Are your audits conducted on-site or remotely?

We provide both on-site and virtual audits, depending on the requirements of the project. For critical assessments, on-site audits are recommended, while virtual audits are ideal for follow-ups and routine inspections.

How do you ensure the suitability of your auditors?

Each auditor is carefully selected based on their expertise in the specific area being audited. They undergo rigorous assessments to ensure they are fully qualified to meet the demands of each unique project.

What industries do you support with your auditing services?

We have experience auditing a wide range of industries, including pharmaceuticals, medical devices, laboratories, API manufacturers, excipient providers, storage facilities, and service providers.

Can you customise an audit to suit my unique requirements?

Yes, we specialise in bespoke audit solutions. Whether it’s assessing technology transfer capabilities or evaluating a facility for specific regulatory standards, we tailor our services to meet your exact needs.

How long does an audit typically take?

The duration of an audit depends on its scope and complexity. Initial assessments for critical suppliers may require several days, while routine follow-ups or virtual audits may be completed in a shorter time frame.

What is included in your audit reports?

Our comprehensive audit reports include detailed findings, identified gaps, recommendations for improvement, and an assessment of compliance with relevant standards. We also provide follow-ups to review CAPA actions and offer final recommendations.

How can I determine if my supplier requires an on-site audit?

Our periodic audit risk assessments evaluate the risks associated with your suppliers. Based on the findings, we can advise whether an on-site or virtual audit is necessary.

How can I get started with Niche Quality’s services?

To begin, simply contact us to discuss your requirements. We’ll review your needs, recommend the appropriate type of audit, and guide you through the next steps to ensure a seamless experience.

Still have questions? Contact us today for personalised assistance with your needs!