eCTD Submission Services for Life Sciences

eCTD Publishing.
Done Right.

The Engine Behind Every Successful Regulatory Submission. eCTD — the electronic Common Technical Document — is the globally accepted standard for regulatory submissions to health authorities worldwide. It is the technical backbone of every modern marketing authorisation application, clinical trial application, variation, renewal and lifecycle submission — and getting it right is not optional. A single technical failure, validation error or formatting issue can result in immediate rejection before a single regulator reads a word of your dossier. In the world of regulatory submissions, technical precision is everything. At BioReg Life Sciences eCTD publishing is not just a service we offer — it is the foundation upon which our entire business was built. With over 5,000 submissions completed, a 100% acceptance rate and some of the most experienced regulatory publishing technicians in the industry, we bring an unmatched level of technical expertise, precision and reliability to every dossier we compile, validate and submit. We use industry leading publishing software — one of the most powerful and widely trusted eCTD publishing platforms in the global regulatory industry. Our in-house publishing capability means every submission is handled entirely within our own secure, validated environment — no outsourcing, no third party dependency, no compromise on quality or timeline. Our technicians know the software, the standards and the submission gateways inside out — and they bring that expertise to every project regardless of size, complexity or urgency. Our publishing process is rigorous, structured and proven. Every dossier undergoes multi-level quality control and comprehensive technical validation before a single file is submitted — ensuring complete compliance with the specific technical specifications of every target regulatory authority. When your dossier leaves BioReg Life Sciences it is submission ready. Not almost ready. Not ready with caveats. Ready. We submit electronically to all major global regulatory authorities via their dedicated submission portals — including the FDA Electronic Submissions Gateway, EMA's CESP portal, MHRA's submissions system and equivalent portals for Health Canada, Swissmedic, TGA and regulatory authorities worldwide. Our team manages the complete submission gateway process — from initial portal registration and account management through to final submission confirmation, receipt acknowledgement and authority acceptance documentation.

Regulatory Documentation Review

Every successful eCTD submission begins long before a single document is published. Getting the regulatory documentation right from the outset is the foundation upon which your entire dossier is built — and the stage where most companies either set themselves up for success or store up problems that surface at the worst possible moment.

At BioReg Life Sciences we begin every publishing project with a thorough regulatory documentation review — conducting a comprehensive gap analysis of your existing documentation against current eCTD requirements and regulatory authority expectations. We assess what you have, identify what is missing and advise on everything needed to build a complete and compliant dossier.

Where documents need to be sourced, structured or authored we work alongside your team — and where necessary draw on our trusted network of regulatory writers and scientific specialists — to ensure every document needed for a successful submission is in place, compliant and ready for the next stage of the process.

Document Preparation

With your regulatory documentation in place the next critical stage is ensuring every document meets the precise technical requirements of the eCTD format before compilation begins. Poorly prepared documents — incorrect formatting, missing metadata, non-compliant file types or inadequate bookmarking — are one of the most common causes of validation failures and authority queries that delay submissions unnecessarily.

At BioReg Life Sciences we conduct a thorough document preparation review across your entire dossier — ensuring every file is fully compliant with current eCTD technical specifications before a single sequence is compiled. Our experienced team handles all aspects of document preparation including bookmarking, hyperlinking, optical character recognition — OCR — formatting corrections and metadata tagging — transforming your source documents into submission ready files that meet the exacting standards of FDA, EMA, MHRA and global regulatory authorities.

Every document that passes through our preparation process is checked, corrected and signed off before moving to compilation — ensuring nothing slips through that could compromise your submission at a later stage.

Lifecycle Management

A successful regulatory submission is the beginning of a long term relationship between your product and its regulatory authorities — not the end of the process.

Post approval, your dossier must be continuously maintained, updated and managed to reflect variations, renewals, safety updates and labelling changes throughout your product's commercial life.

At BioReg Life Sciences we provide comprehensive lifecycle management services for all clients following initial submission — storing your complete approved dossier securely within our industry leading Freyr document management system for future updates, variations and renewals.

This means every subsequent submission builds on a clean, validated and fully maintained dossier baseline — saving you significant time and cost on every future regulatory activity.Our lifecycle management service covers post approval variations, product renewals, PSUR submissions, labelling updates and authority interaction management — all managed by the same senior team who handled your original submission.

With your dossier in our system and our team managing your lifecycle, your product stays compliant, your submissions stay accurate and your investment in approval is fully protected.

Submit to Authorities

With your dossier compiled, published and validated to the highest standard, BioReg Life Sciences manages the complete submission process to your target regulatory authorities — taking full ownership of every step from initial submission through to receipt confirmation and beyond.

We submit your complete eCTD dossier directly to FDA, EMA, MHRA and global regulatory authorities on your behalf — managing the technical submission process through the relevant electronic submission gateways including the FDA Electronic Submissions Gateway, EMA's CESP portal and MHRA's submissions system.

Once submitted we provide you with full submission receipts, acknowledgement confirmations and authority acceptance documentation — giving you complete visibility and confidence that your dossier has been received and accepted.Where the client prefers to manage the submission themselves we provide full support and guidance throughout the process — ensuring every technical requirement is met and every submission gateway protocol is followed correctly.

Either way, BioReg Life Sciences ensures your submission reaches the right authority in the right format at the right time.

Publishing and Validation

Publishing and validation is the most technically demanding stage of the eCTD process — and the one where experience, precision and the right technology make all the difference.

A dossier that fails technical validation is rejected before a single regulator reads a word of it — making this stage critical to the success of your entire submission programme.At BioReg Life Sciences we publish and validate every regulatory dossier using industry leading Freyr software — one of the most trusted and widely used eCTD publishing platforms in the global regulatory industry. Every submission undergoes comprehensive technical validation against the full suite of FDA, EMA and MHRA eCTD technical specifications — identifying and resolving any issues before submission rather than after.

Our rigorous quality check process goes beyond automated validation — every dossier is manually reviewed by our experienced publishing team to ensure structural integrity, hyperlinking accuracy, metadata compliance and overall submission readiness. With over 5,000 submissions completed and a 100% acceptance rate, our quality standard speaks for itself.

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Compilation

With all documents prepared and validated to eCTD technical standards, the compilation stage brings your complete regulatory dossier together into a single structured and navigable submission package.

This is where the technical precision and deep publishing expertise of BioReg Life Sciences makes the critical difference between a submission that sails through technical screening and one that is rejected before it is even reviewed.At BioReg Life Sciences we convert and organise all your regulatory documents into the correct eCTD format — applying the precise module structure, XML backbone, metadata and sequencing required by your target regulatory authority.

Every document is correctly placed within the eCTD hierarchy, fully hyperlinked between sections and bookmarked to the standard that FDA, EMA and MHRA expect.Our compilation process follows rigorous internal quality procedures — ensuring every element of your dossier is correctly structured, consistently formatted and technically compliant before it moves to the publishing and validation stage.

The result is a clean, complete and professionally compiled regulatory dossier ready for final publishing.

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Comprehensive eCTD Publishing

Submission Types We Cover.

With BioReg Life Sciences managing your eCTD publishing programme — from initial document preparation through to global submission and post approval lifecycle maintenance — you have the most experienced publishing team in the industry working for you. The process is locked down. The quality is guaranteed. And your submission will be done right.

Initial Applications and Regions

NDA — New Drug Application — FDA
MAA — Marketing Authorisation Application — EMA & MHRA
BLA — Biologics Licence Application — FDA
ANDA — Abbreviated New Drug Application — FDA
IND — Investigational New Drug — FDA
CTA — Clinical Trial Application — MHRA & EMA
IMPD — Investigational Medicinal Product Dossier

We have the resources to submit submissions across every market globally

Variations, Lifecycle and Renewals

Type IA, IB and II Variations — EMA & MHRA
Prior Approval Supplements — FDA
Changes Being Effected Supplements — FDA
Line Extensions
Labelling Updates & Variations
PSUR — Periodic Safety Update Reports
PBRER — Periodic Benefit Risk Evaluation Reports
Annual Reports — FDA
DSUR — Development Safety Update Reports

Specialised Submissions

ATMP — Advanced Therapy Medicinal Product submissions
Orphan Drug Applications
Paediatric Investigation Plans — PIPs
Scientific Advice Dossiers
Briefing Documents
Legacy Submission Conversions to eCTD
NeeS — Non eCTD Electronic Submissions
Paper to eCTD Conversion

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.

eCTD Publishing. Done Right.