BioReg Life Sciences: The Regulatory Affairs Partner Built for the Future of Life Sciences Regulatory Affairs. Done Right.

The life sciences industry is at an extraordinary moment. Gene therapies that were once the stuff of science fiction are reaching patients. Cell therapies are reshaping oncology. Medical devices are becoming smarter, more connected and more therapeutically significant than ever before. And the pipeline of innovative medicines moving through clinical development is broader, more diverse and more scientifically ambitious than at any point in the history of the industry.

But with that ambition comes complexity. Regulatory complexity that is growing faster than most life sciences companies can keep pace with. A post Brexit landscape that has fundamentally changed the UK and EU regulatory dynamic. An FDA that is navigating its own period of significant evolution. And a global regulatory environment that demands more rigour, more documentation and more strategic intelligence than at any previous point in history.

This is the world BioReg Life Sciences was built for. And we are ready.

Who We Are

BioReg Life Sciences is a full service regulatory affairs consultancy serving pharmaceutical, biotech, gene and cell therapy and medical device companies across the UK, Europe, the United States and global markets. We provide complete end to end regulatory support — from the earliest strategic decisions at Phase 2 through to marketing authorisation submission, approval and the lifetime of post approval compliance that follows.

We are built on a foundation of genuine, hard won expertise. Our founding team brings over 60 years of combined regulatory affairs experience — accumulated at the highest levels of the industry, inside the world’s largest and most respected contract research organisations and global pharmaceutical companies. We have led regulatory affairs functions at major CROs. We have managed complex global submission programmes across every major therapeutic area. We have trained regulatory professionals across the world. And we have delivered thousands of successful submissions to regulatory authorities on every continent.

Our track record speaks for itself — over 5,000 submissions completed and a 100% acceptance rate. Not a marketing claim. A standard we hold ourselves to every single day.

But what makes BioReg Life Sciences genuinely different is not just the depth of that experience. It is how we deliver it.

At the scale of a major CRO, clients become projects. Submissions become tickets. The personal relationship, the senior oversight and the genuine investment in your product’s success gets lost in the machinery of a large organisation. We have seen it happen. We have experienced it from the inside. And it is precisely why BioReg Life Sciences exists.

Every client who works with BioReg Life Sciences works directly with senior regulatory consultants who bring decades of real world experience to their specific challenge. There are no junior hand offs, no account management layers and no distance between the people you speak to and the people delivering your regulatory programme. You get the full weight of our expertise — applied personally, precisely and with complete accountability — from the first conversation to the final submission and beyond.

The Team Behind BioReg Life Sciences

BioReg Life Sciences was co-founded by two regulatory affairs professionals whose partnership was forged not in a boardroom but through years of delivering together at the highest levels of the industry inside major CROs and global pharmaceutical companies. That shared history — the trust, the working relationship and the aligned vision — is the foundation everything else is built on.

Cheryl Allen — Co-Founder & Director of Regulatory Affairs

Cheryl Allen is one of the most experienced regulatory affairs professionals in the world. With over 40 years in the field, Cheryl has spent her career at the absolute forefront of the industry — leading regulatory teams at major CROs and large pharmaceutical companies, managing complex global submission programmes and training regulatory professionals across the world.

Her experience spans thousands of product submissions and renewals across FDA, EMA, MHRA and global regulatory authorities — covering pharmaceuticals, biologics, gene therapy and medical devices across every major therapeutic area and market.

Most remarkably — Cheryl managed the first ever eCTD submission in the world. A milestone moment in the history of regulatory affairs that cemented her place as a true pioneer of the field. From that historic first submission to the thousands that have followed across four decades of outstanding regulatory practice, her commitment to precision, compliance and excellence has never wavered.

At BioReg Life Sciences, Cheryl’s extraordinary depth of knowledge and experience underpins the technical quality of everything we deliver — ensuring our work is always beyond question.

Thomas Marsden — Co-Founder & CEO

Thomas Marsden brings extensive commercial and operational expertise to BioReg Life Sciences, built across a career spanning major global CROs and the life sciences industry. With deep experience in regulatory operations, business development and client management across US, EU, China and global markets, Thomas has spent his career understanding what life sciences companies truly need from their regulatory partners — and more importantly, what they too often fail to receive.

Thomas leads the commercial strategy and client relationships at BioReg Life Sciences — ensuring every client receives the senior attention, clear communication and results driven service that the complexity of their regulatory journey demands. Based across Nottingham and London, he brings the commercial acumen, industry network and operational drive to match Cheryl’s unparalleled technical expertise.

Together, supported by a team of senior regulatory consultants, scientific specialists and trusted partners across global markets, Thomas and Cheryl have built a consultancy that combines world class regulatory knowledge with genuine business partnership — giving life sciences companies the complete regulatory solution they need to get their products to market and keep them there.

What We Do

BioReg Life Sciences provides a complete, end to end regulatory affairs service structured around four core pillars — each representing a critical and distinct stage of the regulatory journey from development to market and beyond.

Plan It Right — Regulatory Strategy & Affairs

Before a single document is written or a submission prepared, the right regulatory strategy makes all the difference between a programme that moves efficiently toward approval and one that stumbles into avoidable delays and costly mistakes.

We work with life sciences companies from Phase 2 onwards — assessing where they stand, defining the optimal pathway to approval and building a clear, actionable roadmap to get there. Our regulatory strategy services cover market entry planning, market sequencing, pathway selection, accelerated designation advisory including PRIME, Fast Track, Breakthrough Therapy and Orphan Drug status, regulatory gap analysis, submission readiness assessment, GMP guidance and compliance advisory, labelling strategy, scientific advice meeting preparation and clinical trial application support across MHRA, EMA, FDA and global markets.

We also provide regulatory coaching, named regulatory consultant services, regulatory due diligence for investors and comprehensive Brexit regulatory support — helping companies navigate the increasingly divergent UK and EU regulatory frameworks with confidence and efficiency.

Most companies leave the regulatory strategy conversation too late. By the time they realise they are underprepared they are already in Phase 3 and the clock is running against them. The companies that reach market fastest are invariably the ones that planned properly at Phase 2. That is exactly what BioReg Life Sciences is here to help you do.

Build It Right — Document Preparation

A regulatory submission is only as strong as the documents behind it. Poorly structured, incomplete or non-compliant documentation is one of the leading causes of regulatory delays, authority queries and outright rejections — setbacks that no life sciences company can afford at a critical stage of development.

At BioReg Life Sciences we take complete ownership of your regulatory document preparation — supporting, reviewing and quality assuring your Module 1 and Module 2 documentation to the highest standard across FDA, EMA, MHRA and global markets.

We draw on our trusted network of specialist regulatory writers for complex document authoring and manage the complete document preparation process from first draft to submission ready final version.

Our comprehensive regulatory document template library gives clients the frameworks, structures and regulatory scaffolding to build compliant documentation efficiently — maintained and updated in line with the latest regulatory guidance across all major markets. And our industry leading document management system ensures every document is version controlled, audit ready and securely stored throughout your regulatory programme.

Submit It Right — eCTD Publishing

When it comes to regulatory submissions there is no margin for error. A single validation failure, technical issue or formatting error can delay your approval by months — and in the life sciences world, time is everything.

With over 5,000 submissions completed and a 100% acceptance rate, eCTD publishing is the absolute core of what we do. Using industry leading Freyr software we compile, validate and submit complete regulatory dossiers to FDA, EMA, MHRA and all major global health authorities — accurately, efficiently and on time, every time.

Our publishing process is comprehensive and rigorous — covering document preparation and compilation, technical validation, multi-level quality checking and electronic submission via all relevant gateway portals. From your first IND or CTA through to a full NDA or MAA, we manage every aspect of the submission process — coordinating all workstreams, managing timelines, liaising with regulatory authorities and ensuring your dossier reaches the right authority in the right format at the right time. No exceptions.

Maintain It Right — Lifecycle Management

Regulatory approval is not the finish line. It is the beginning of an ongoing compliance commitment that demands continuous expert attention throughout the commercial life of your product. Post approval, every product must remain continuously compliant — through variations, renewals, labelling updates, safety reporting and regular regulatory authority interactions that require the same level of precision and expertise as the original submission.

BioReg Life Sciences provides comprehensive lifecycle management services — covering post approval variations, PSUR and PBRER submissions, product renewals, labelling updates, post market surveillance, authority query management and ongoing regulatory retainer support. Your full regulatory dossier is securely hosted in our managed document system — giving you continuous access to your complete submission history, compliance records and regulatory documentation at all times.

Our lifecycle retainer service gives clients dedicated ongoing regulatory support, proactive compliance monitoring and priority access to our senior team — ensuring your product stays compliant, your submissions stay accurate and your investment in market authorisation is fully protected year after year.

The Industries We Serve

BioReg Life Sciences works with companies across three primary life sciences verticals — each with their own distinct regulatory challenges, unique submission requirements and specific compliance obligations that demand genuine specialist knowledge.

Medicines — pharmaceuticals, biologics, biosimilars and vaccines — navigating NDA, MAA and BLA pathways across FDA, EMA and MHRA for products at every stage of development.

Gene & Cell Therapy — ATMPs, CAR-T, viral vectors and advanced biological therapies — one of the most complex and rapidly evolving regulatory landscapes in the industry, requiring specialist knowledge of EMA’s Committee for Advanced Therapies, MHRA’s ATMP framework and FDA’s gene therapy specific guidance.

Medical Devices — Class I through Class III devices, combination products and IVDs — managing UKCA and CE marking requirements, MHRA registration, FDA 510k and PMA pathways and the dual UK and EU compliance demands of the post Brexit regulatory environment.

Our Global Reach

BioReg Life Sciences serves clients across UK, European, US and global markets — managing submissions to MHRA, EMA, FDA, Health Canada, Swissmedic, TGA and regulatory authorities worldwide. Our network of trusted scientific partners, regulatory specialists and medical writers extends our capability across every module of the eCTD dossier — giving clients access to a complete, fully managed regulatory solution through a single trusted point of contact.

For companies seeking approval across multiple markets simultaneously, our multi-regional submission coordination service manages the entire global programme — ensuring consistency, efficiency and compliance across every jurisdiction.

The BioReg Life Sciences Difference

The life sciences industry deserves better than the choice between an impersonal CRO and an under-resourced small consultancy. It deserves a partner that combines genuine senior expertise with personal accountability. A partner that understands the science, knows the regulators, has delivered thousands of successful submissions and is completely and personally invested in getting your product to the patients who need it.

That is BioReg Life Sciences.

We bring the expertise of a major CRO. We deliver with the personal attention of a dedicated partner. And we hold ourselves to a standard — a 100% submission acceptance rate — that reflects our absolute commitment to excellence on every single project we take on.

If you are a life sciences company with a product that deserves to reach patients — we are the regulatory partner you have been looking for.

Regulatory Affairs. Done Right.

If you are working in life sciences and navigating the regulatory journey — I would love to connect and explore how BioReg Life Sciences can support your programme.

Regulatory Affairs. Done Right.

📍 Nottingham & London

🌐 www.bioreglifesciences.com

📧 thomas.marsden@bioreglifesciences.com