End to End Regulatory Affairs Services for Life Sciences

Gene and Cell Therapy.
Regulatory Done Right.

Gene and cell therapy represents the most exciting frontier in modern medicine — and also the most complex regulatory landscape in the life sciences industry. Unlike traditional small molecule drugs or even biologics, ATMPs (Advanced Therapy Medicinal Products) involve modifying or replacing a patient's own genetic material or using living cells as medicine. This fundamental difference creates unique regulatory challenges that standard pharmaceutical frameworks were never designed to address. The regulatory pathway for gene and cell therapies is demanding at every stage. From Chemistry, Manufacturing and Controls (CMC) considerations that are far more complex than traditional biologics, to nonclinical study requirements that must account for long-term integration and potential off-target effects, to clinical trial designs that often involve small patient populations and single-arm studies — every module of the eCTD dossier requires specialist knowledge. Regulatory authorities including the MHRA, EMA and FDA have developed specific guidance for ATMPs, and staying current with evolving requirements is essential. At BioReg Life Sciences, we bring deep expertise in gene and cell therapy regulatory affairs. Our team has supported ATMP developers through successful submissions to global authorities, with a 100% acceptance rate across thousands of filings. We help you navigate the entire journey — from early regulatory strategy and scientific advice meetings, through CTA and IND preparation, to full Marketing Authorisation Applications and post-approval lifecycle management. With the UK representing over 57% of all European ATMP clinical trials, there has never been a better time to partner with a UK-based specialist who truly understands this space. Whether you are developing CAR-T, gene replacement therapies or CRISPR-based treatments, BioReg Life Sciences provides the regulatory expertise and hands-on support to get your therapy to patients. Regulatory Affairs for Gene & Cell Therapy. Done Right.

Regulatory Gap Analysis

Before you can move forward with confidence, you need to know exactly where your regulatory dossier stands. A dossier gap analysis is the most honest assessment a life sciences company can commission—yet most leave it too late, or never do it at all.

At BioReg Life Sciences, we conduct a comprehensive, no surprises review of your existing regulatory dossier against the specific requirements of your target markets—whether that is the MHRA, EMA, FDA or global authorities.

We examine every module, every document and every technical requirement, identifying deficiencies, missing data, formatting errors and compliance risks that could delay or derail your submission.Our consultants bring decades of hands on experience reviewing thousands of dossiers across pharmaceuticals, biologics and gene therapies.

We know exactly what regulators look for, what they reject and why.We deliver a clear, prioritised roadmap showing exactly what needs to be fixed, in what order and by when.

Whether you are preparing for your first submission, recovering from a previous rejection, or planning a complex global filing, our dossier gap analysis gives you the clarity and control to move forward with confidence.With BioReg Life Sciences, submission readiness is not a gamble. It is a process.

Artwork and Labelling

Product labelling is a regulated document, not just a packaging decision. The SmPC and Patient Information Leaflet must meet strict regulatory requirements for content, language and format — and any change requires a formal variation submission.

At BioReg Life Sciences, we ensure your labelling text is fully compliant with MHRA, EMA and FDA requirements. We review SmPCs and PILs against the approved dossier, confirm QRD template compliance (for EU) or MHRA format (for UK), check patient-friendly language requirements, and manage labelling variations as part of your product lifecycle.

What we do not do is creative artwork or packaging design. That is a specialist service we can help you source — but our role is regulatory compliance, not graphic design.

With decades of experience reviewing and approving thousands of SmPCs and PILs across global markets, we ensure your labelling text meets regulator expectations before it ever goes to print.

Lifecycle Management

Regulatory approval is not the finish line — it is the beginning of an ongoing compliance commitment. Post approval, your product must remain continuously compliant through variations, renewals, labelling updates, safety reporting and regular interactions with regulatory authorities. For many companies this is where the cracks start to appear.

At BioReg Life Sciences we manage your complete regulatory lifecycle so they never do. From post approval variations and PSUR submissions to authority query management and product renewals, we handle every obligation with the same precision we bring to initial submissions. Your full regulatory dossier is securely hosted in our managed document system, giving you continuous access to your submission history and compliance records at all times.

With BioReg Life Sciences managing your lifecycle, your product stays compliant, your team stays focused and your business keeps moving forward.

Regulatory Strategy

Regulatory strategy is the single most important decision you will make before a single document is written. Choosing the wrong market first, the wrong approval pathway or the wrong sequence of submissions can cost years of delay and millions in lost opportunity.

At BioReg Life Sciences, we work with you from Phase 2 onwards to build a clear, practical regulatory roadmap that aligns with your science and your commercial goals. We help you answer the critical questions: Should you go to the FDA or EMA first? Which accelerated pathways are you eligible for—Fast Track, Breakthrough Therapy, PRIME or Orphan Drug Designation? What is the most efficient sequence to secure global approvals without duplicating effort?

Our senior consultants bring decades of experience inside major CROs and global pharma companies, giving you access to strategic intelligence that most boutique consultancies cannot offer. We assess your product, your data package and your target markets, then deliver a step by step plan that minimises risk, reduces uncertainty and accelerates your route to patients.

With BioReg Life Sciences guiding your regulatory strategy, you move forward with confidence—knowing every decision has been made for speed, efficiency and success.

Regulatory Submissions and eCTD Publishing

Submitting a regulatory application to the MHRA, EMA or FDA is the culmination of years of development and investment. It must be right. There is no margin for error.

At BioReg Life Sciences, we manage the end-to-end submission process — from initial planning through to submission confirmation and authority query management. Our team has completed over 5,000 submissions across global markets with a 100% acceptance rate. We know what works, what regulators expect and how to avoid the common pitfalls that delay approvals.

eCTD publishing is the technical backbone of every modern submission. Using industry leading Freyr software, we compile, hyperlink, validate and quality check your complete eCTD dossier to ensure full technical compliance with MHRA, EMA, FDA and all major global health authorities. Every document, every hyperlink, every bookmark and every piece of metadata is checked before your submission ever leaves our hands.

We act as your single point of contact throughout — coordinating all workstreams, managing authority queries and ensuring nothing falls through the cracks. Whether this is your first submission or your fiftieth, BioReg Life Sciences brings the senior expertise, technical precision and project management rigour to get your application approved.

Lifecycle Management

With BioReg Life Sciences managing your lifecycle, your product stays compliant, your team stays focused and your business keeps moving forward.

Lifecycle Management

With BioReg Life Sciences managing your lifecycle, your product stays compliant, your team stays focused and your business keeps moving forward.

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Promotional Material Review & Submissions

Before any promotional material for a prescription medicine reaches healthcare professionals or patients, it must comply with strict regulatory standards. In the UK, materials must be submitted to the MHRA and comply with the ABPI Code of Practice. In the US, the FDA requires promotional submissions via Form FDA 2253. Getting it wrong can result in warning letters, compliance action and serious reputational damage.

At BioReg Life Sciences, we review your promotional and marketing materials before they are finalised — ensuring every claim is accurate, supported by the approved label, and compliant with relevant codes and regulations. Our service covers sales aids, patient brochures, digital content, press releases and congress materials.

We then manage the formal submission process to regulatory authorities where required — including MHRA, FDA and relevant European national authorities.

Cheryl Allen, our Co-Founder, brings direct experience in promotional submissions from her decades inside major CROs and global pharma companies. She knows what regulators expect — and what will trigger a rejection.

Whether you need a one-off review or ongoing support, we ensure your promotional materials reach the right audiences — compliantly and confidently.

Regulatory Document Templates

For early-stage biotech and pharmaceutical companies, knowing where to begin with regulatory documents is often the biggest hurdle. What format? What headings? What does the regulator actually expect to see?

At BioReg Life Sciences, we solve this problem with submission-ready M1 and M2 document templates — built directly from our experience delivering over 5,000 successful submissions to MHRA, EMA and FDA.

Module 1 templates cover cover letters, application forms, SmPCs, Patient Information Leaflets, labelling and Risk Management Plans.

Module 2 templates cover the Quality Overall Summary, Clinical Overview, Nonclinical Overview and Summary of Clinical Efficacy and Safety.

These are not generic internet downloads. They are practical, proven templates structured by Cheryl Allen — with over 40 years of regulatory experience including the world's first eCTD submission. Each template includes guidance notes showing your team exactly what information to include.

Whether purchased individually or as a fixed-fee starter pack, our M1 and M2 templates give your internal team the structure and confidence to begin writing compliant documents from day one.

Medical Writing Support

Regulatory submissions require precise, compliant and scientifically robust documentation at every stage. Whether you need support structuring your regulatory documents, an expert review of existing content or access to specialist medical writers, BioReg Life Sciences is here to help.

We provide hands-on support and quality review across Module 1 and Module 2 documentation — ensuring your administrative documents, summaries and overviews are accurate, complete and submission-ready before they ever reach a regulatory authority.

Where specialist medical writing is required for more complex regulatory documents, we draw on our trusted network of experienced regulatory writers and scientific specialists — providing seamless third party writing support managed and quality assured by BioReg Life Sciences throughout the process.

For Module 3, 4 and 5 requirements, our established network of CMC specialists, nonclinical experts and clinical writers ensures your complete dossier is supported by the right expertise at every stage — all coordinated through one trusted partner.

CTA & IND Support

Initiating a clinical trial for a gene or cell therapy product requires navigating one of the most technically demanding and scrutinised application processes in the regulatory world. Clinical Trial Authorisations for ATMPs are assessed against unique safety, manufacturing and quality standards that go far beyond those applied to traditional pharmaceutical products — and a poorly prepared application can delay your programme by months before a single patient is treated.

At BioReg Life Sciences we provide comprehensive CTA and IND support for gene and cell therapy companies — guiding you through every stage of the application process from initial preparation through to submission and authority response management. We work with your team to ensure your clinical trial application meets the specific requirements of MHRA, EMA and FDA for ATMP programmes — covering documentation preparation, dossier structuring, regulatory correspondence and query management.

Whether you are submitting your first in human gene therapy trial or expanding an existing programme into new markets, our experienced team ensures your application is complete, compliant and submission ready.

GMP & Compliance Support

Gene and cell therapy manufacturing operates under some of the most stringent and complex Good Manufacturing Practice requirements in the life sciences industry. ATMPs are living biological products — their manufacturing processes are inherently variable, technically demanding and subject to highly specific GMP frameworks that standard pharmaceutical manufacturing guidelines were not designed to address.

At BioReg Life Sciences we provide specialist GMP and compliance support for gene and cell therapy companies — helping you understand, implement and demonstrate the manufacturing quality standards required by MHRA, EMA and FDA for ATMP programmes.

Our senior team conducts GMP gap analyses, supports inspection readiness, advises on quality management system development and provides practical guidance on the specific GMP requirements for viral vectors, CAR-T manufacturing and other advanced therapy modalities.

Whether you are setting up your manufacturing process for the first time, preparing for a regulatory inspection or responding to a GMP compliance finding, BioReg Life Sciences provides the expert support you need to meet the standard regulators expect.

Why choose BioReg Life Sciences for your regulatory needs?

BioReg Life Sciences supports pharmaceutical, biotech and gene therapy companies with every stage of the regulatory journey — from early development through to post-authorisation and lifecycle management. Whatever your regulatory challenge, our senior consultants work with you to build a balanced, realistic and achievable strategy that aligns with your company's vision. We manage and publish your submissions, advise on complex regulatory requirements, and support your successful market launch and ongoing compliance.Talk to us for an open, no-obligation conversation about how we can help.

Gene and Cell Therapy. Regulatory Done Right.

Regulatory Gap Analysis

Why choose BioReg Life Sciences for your regulatory needs?

Gene and Cell Therapy.
Regulatory Done Right.