Who we are

ReguLogix Consulting Ltd is an exciting early-stage QA/RA consultancy specialising in the global medical devices industry with extensive experience in Medical Devices, In Vitro Diagnostics (IVDs) medical devices, Software and AI as Medical Devices, and Combination Products. ReguLogix Consulting Ltd is led by Nataliya Noreika, a experienced professional with a distinguished career in Regulatory Affairs and Quality Assurance.

Nataliya Noreika

BSc(Hons), MSc, RAC (US, EU, Global, Device, Drugs, Biologics)

Founder and Principal Consultant

With over 14 years of hands-on experience navigating complex regulatory frameworks, Nataliya offers comprehensive expertise to ensure compliance with worldwide medical device regulations. Previously, she was Head of Quality and Regulatory at several medical device companies; she has successfully managed the certification of Quality Management Systems (QMS), facilitated regulatory approvals across multiple jurisdictions, and optimised compliance practices to align with the latest industry regulations.

With an MSc from the National University of Life and Environmental Sciences of Ukraine and a BSc from Munster Technological University in Ireland, she has been committed to ensuring product safety and global regulatory compliance for many years.

She is also PRINCE 2 certified in Project Management, a certified lead Quality Systems auditor, a member of the Regulatory Affairs Professional Society (RAPS). She holds the RAPS Regulatory Affairs Certificate (RAC) credential for Global Medical Devices, Drugs and Biologics. She has a proven track record in guiding products from concept to market, guaranteeing overall customer satisfaction.

Our Ethos

Mission: ReguLogix Consulting’s mission is to provide compliance solutions that prioritise patient safety and well-being.

Vision: We aspire to become the universally trusted partner of choice, offering pragmatic solutions to our clients' regulatory and quality compliance needs. We aim to embody trustworthiness, be the preferred choice, and achieve universal recognition.

The company's core values: Connected, Flexible, Knowledgable, Trusted, and Accountable

Connected:We believe in fostering strong connections with clients and stakeholders to deliver collaborative and effective solutions.
Flexible: We adapt to the evolving needs of clients and industry, ensuring flexibility in our approach and services.
Knowledgeable: Our expertise and continuous learning enable us to provide informed and insightful guidance to clients.
Trusted:We prioritise trust by upholding the highest standards of integrity, transparency, and reliability.
Accountable: We take responsibility for our actions and commitments, delivering results with accountability and professionalism.

These values are fundamental to our identity and guide us in achieving our vision at all times.

Get in Touch with Us

Discover the flexible ways you can engage with our services based on your company's specific requirements. 
We offer the following options, which can be customised to align perfectly with your business needs:

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