Your Partner in Pharmaceutical Quality Excellence

At Niche Quality Ltd., we partner with you to master pharmaceutical quality, delivering tailored solutions that ensure compliance and drive success at every step.

Claire Nowlan, Quality & Regulatory Consultant

OUR SERVICES

Expertise

Integrity

Excellence

Our Story,

Our Journey

Niche Quality Ltd began with a clear purpose: to guide life sciences companies in navigating the often-daunting world of regulatory compliance.

Established in Ireland, we’ve expanded our reach globally, working with companies of all sizes, from local innovators to multinational giants.

Our services include designing effective quality management systems, validating essential processes, and providing the expertise of Responsible and Qualified Persons.

Every solution we craft is grounded in our core values of Quality, Trust, Reassurance, and Intelligence, ensuring that each client receives tailored and practical support.

By partnering with us, you gain not only a trusted advisor but also a long-term ally dedicated to helping you thrive in an ever-changing, regulated landscape.

HAPPY cLIENTS

100%

We aim for 100% satisfaction.

Projects

100+

We've successfully completed 100s of projects, delivering outstanding results every time.

COMPLIANCE

100%

We work with our clients to achieve a 100% compliance success across all projects!

TEAM EXPERTISE

80+ Years

Our experienced team provides over 80 combined years of excellence in pharmaceutical quality

COMMITMENT

100%

With our unwavering dedication, we give 100% commitment to every project we undertake.

Our Team,

Force behind our Success

Meet the dynamic individuals at the heart of our success. From innovative thinkers to skilled strategists, each team member plays a crucial role in driving progress.

Together, we build a collaborative environment where creativity thrives and groundbreaking solutions emerge.

Dive into their inspiring journeys, learn about their unique expertise, and celebrate the shared commitment to excellence that fuels our team.

Claire Nowlan, Quality and Regulatory Consultant

Claire is a Quality and Regulatory Consultant at Niche Quality Ltd, specializing in quality management systems, validation, and auditing.

She provides guidance on meeting global regulatory standards, develops customized validation strategies, conducts detailed audits, and trains teams to ensure compliance and improve operations.

Giles Durcan, Responsible Person

Giles, a leader in pharmaceutical distribution, has honed nearly 30 years of experience, transitioning from United Drug to DSV.

He pursued varied roles in FMCG sales and public service before excelling in logistics. He has revolutionized the sector with innovations in warehousing and client services. Outside of work, he enjoys exploring Ireland’s waterways on his canal barge.

Mike Smith, Lead Compliance Engineer

In pharma, compliance with FDA 21 CFR P11 and Eudralex Annex 11 is essential but complex. With 30+ years of proven expertise, Mike provides solutions tailored to meet strict regulations while optimizing efficiency.

From sterile fill-finish systems to computer validation, his work ensures operational success.

Carol Furlong, Regulatory Consultant

Carol brings over 20 years of experience within the biopharmaceutical and pharmaceutical sectors.

Her career has encompassed roles across industry, consultancy, and regulatory agency environments, offering a well-rounded and in-depth understanding of the global regulatory landscape.

Karoline Coutinho, Quality & Validation Associate

With 7 years in global pharmaceutical companies, Karoline brings expertise in quality systems and compliance where she built a process-focused mindset and a commitment to continuous improvement.

Karoline has led large technical teams, overseen critical systems, and partnered with stakeholders to strengthen quality frameworks across hospitals and Renal Care Centres. She thrives on resolving issues and driving progress.

Cynthia Durack, Marketing and Compliance Specialist

Cynthia bridges the gap between compliance and market positioning.

Her expertise in pharmaceuticals and medical devices allows her to craft strategies that enhance brand visibility, build trust, and drive business growth, ensuring execution aligns with industry regulations.