GRS Joins the Health & Life Sciences Pledge to Strengthen Regulatory Support in North East and North Cumbria.

Global Regulatory Services (GRS) is proud to announce our active participation as a pledgee in the Health & Life Sciences Pledge (HLS Pledge), an initiative dedicated to fostering innovation and tackling regional health challenges in the North East and North Cumbria (NENC). By joining this network of committed organisations, GRS reaffirms its mission to support health and life sciences companies by reducing regulatory risks and empowering innovators to bring transformative products to market.

At GRS, we believe that collaboration, communication, and celebration are integral to advancing the life sciences industry. Through the HLS Pledge, we are committed to sharing knowledge, working transparently with stakeholders, and championing success stories that inspire further innovation.

Supporting Innovation Through Regulatory Excellence

Global Regulatory Services (GRS) is a recognised leader in international regulatory and quality compliance services for the life sciences sector. With clients ranging from innovative start-ups to global corporations, we offer tailored, holistic solutions designed to meet our industry's unique regulatory challenges.

Our expertise spans a diverse range of sectors, including:

• Medical Devices and In Vitro Diagnostics (IVDs): Comprehensive support for regulatory submissions, market access, and compliance with global standards.
• Pharmaceuticals and Regenerative Therapies: End-to-end guidance on regulatory approvals, including advanced therapies and novel drug products.
• Functional Foods and Nutraceuticals: Navigating complex regulatory landscapes for food supplements and functional ingredients.
• Borderline Products: Expertise in classifying and regulating products that straddle multiple categories.

By joining the HLS Pledge, GRS aims to bring this expertise to the vibrant health and life sciences ecosystem in NENC, reducing regulatory risks for businesses and helping them achieve compliance more efficiently.

Services to Accelerate Innovation

GRS provides extensive services to help life sciences companies address regulatory challenges and launch their products successfully. Our key offerings include:

1. Regulatory Strategy Report: Tailored roadmaps for achieving compliance in multiple jurisdictions.
2. Quality Management Systems (QMS): Develop and implement robust QMS to meet ISO and FDA standards.
3. Representation Services: Acting as EU Authorised Representative (EUAR), UK Responsible Person (UKRP), Person Responsible for Regulatory Compliance (PRRC), and UK Regulatory Virtual Importer (UKRVI).
4. Local and International Regulatory Submissions: Managing submissions for market entry in the UK, EU, USA, and beyond.
5. Fractional Regulatory Consultancy Services: Flexible, on-demand regulatory support tailored to client needs.

As a pledgee, we offer FREE strategy calls to discuss priority requirements and pathways. First-time enquirers can leverage this opportunity to understand their regulatory landscape and identify solutions tailored to their goals. Additionally, eligible companies can benefit from preferential rates based on their specific needs and the scope of required services.

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Supporting Non-UK Companies with UK Market Access

For non-UK companies aiming to enter the UK market, GRS offers unparalleled support through our UK Responsible Person (UKRP) and UK Regulatory Virtual Importer (UKRVI) services. These roles are critical for ensuring compliance with post-Brexit regulations, enabling seamless market access for medical devices, pharmaceuticals, and other life sciences products.

Our comprehensive UKRP and UKRVI services include:

• Representation before the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
• Ensuring compliance with UK Medical Device Regulations (UK MDR).
• Managing regulatory submissions and product registrations.

Additionally, through our subsidiary companies, GRS extends its services to support UK-based organisations with EU market access. Acting as an EU Authorised Representative (EUAR) and European Responsible Person (EURP), we help clients navigate the stringent requirements of EU regulatory frameworks, ensuring their products meet all necessary standards for distribution across Europe.

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Commitment to the NENC Region

The NENC region is home to a thriving health and life sciences sector with a strong emphasis on innovation, collaboration, and addressing unmet healthcare needs. Through the HLS Pledge, GRS is dedicated to:

1. Communicating: Sharing regulatory insights and best practices to help companies in the region achieve compliance efficiently and effectively.
2. Collaborating: Partnering with stakeholders across academia, industry, and healthcare to reduce regulatory bottlenecks and accelerate innovation.
3. Celebrating: Highlighting success stories from the region to inspire and motivate other innovators.

By leveraging our global network of regulatory professionals, GRS is uniquely positioned to bring international expertise to the local ecosystem and foster a culture of innovation that transcends borders.

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A Partner for Every Stage of the Journey

Whether you are an early-stage start-up developing a novel medical device or an established company expanding into new markets, GRS is here to support you every step of the way. Our holistic approach ensures that your regulatory and quality compliance needs are met with precision, allowing you to focus on what matters most: delivering value to patients and customers.

Our team’s deep understanding of global regulatory frameworks enables us to provide targeted solutions that minimise risk and maximise opportunity. By working with GRS, companies can confidently navigate the complex regulatory landscapes of the UK, EU, and beyond.

Join Us in Building a Healthier Future

As a proud pledgee of the HLS Pledge, GRS is excited to contribute to the growth and success of the health and life sciences sector in North East and North Cumbria and beyond. Together, we can tackle regional health challenges, reduce inequalities, and pave the way for groundbreaking innovations that improve lives worldwide.

To learn more about how GRS can support your regulatory and quality compliance needs, visit our website or reach out to us directly:

Global Regulatory Services [email protected] https://globalregulatoryservices.com/

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About the Health & Life Sciences Pledge

The Health & Life Sciences Pledge is a collaborative initiative to drive innovation in North East and North Cumbria. By fostering partnerships, sharing knowledge, and celebrating successes, the pledge creates an ecosystem where companies can thrive and make a meaningful impact on healthcare challenges. For more information, visit https://hlspledge.org.uk/.

GRS is honoured to be part of this dynamic community and looks forward to making a lasting contribution to its success. Together, we can build a healthier future for all.

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