Life-Science Regulatory Submissions
Regulatory
Submissions
The filings that carry a drug, biologic,
or device to market — built to be accepted.
The filings that carry a drug, biologic,
or device to market — built to be accepted.
A regulator never sees your laboratory, your factory, or your clinical team. It sees a submission — the structured application that carries your evidence to the agency and asks for a decision. Each product type is filed differently: a small-molecule drug, a biologic, and a medical device share almost nothing in application, evidence, or format, and each is reshaped again for every market. We build the right submission for the product in hand, filed to the standard of the agency that will read it, in the United States, the European Union, and beyond.
Thousands of documents, assembled to read as a single, defensible application.
Most submission strategies are built around two poles. The FDA runs the world's most exacting review; the European Union offers not one filing but a choice of procedures across twenty-seven member states. Win both and the rest of the world often follows.
Drugs and biologics file to CDER and CBER on the electronic CTD; devices file to CDRH on their own templates. Every submission is validated at the gateway before a reviewer ever opens it.
Medicines route centrally through the EMA or nationally across member states; devices earn a CE mark through a notified body and register in EUDAMED. The route you pick decides the timeline.
The application you file, the evidence it carries, and the format it takes all change with the product. Here is how each one reaches FDA and the EU.
From the first investigational application through approval and a lifetime of supplements, small-molecule drugs are filed on the CTD backbone — but the FDA and the EU ask for them in very different ways.
Investigational New Drug application to open clinical development, cleared in 30 days.
The full New Drug Application, built on the sponsor's own safety and efficacy data.
An NDA that leans on prior findings or published literature to reach approval faster.
Abbreviated application for generics, turning on bioequivalence to the reference drug.
Efficacy and CMC supplements and annual reports that carry the drug through its life.
A single EMA application yielding one authorisation valid across every member state.
A simultaneous filing through a reference member state, extended to chosen concerned states.
An existing national approval recognised by additional member states.
Authorisation in a single member state, often the first step before wider recognition.
Type IA, IB, and II variations and renewals that maintain the marketing authorisation.
One core dossier, a US regional Module 1 and an EU Module 1, filed to each agency's rules.
Monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars are filed where manufacturing and comparability carry the application. In the EU, the biggest of them have no choice of route at all.
The investigational application that opens a biologic's clinical program.
The original Biologics License Application for a new biologic.
The biosimilar pathway, built on analytical and clinical comparability to a reference product.
The additional data supporting a biosimilar's substitution at the pharmacy.
Cell and gene therapies filed to CBER, often with expedited designations attached.
Mandatory for biotech products and advanced therapies — there is no national route.
Centrally assessed against the reference biologic, on the EU's mature biosimilar framework.
Cell, gene, and tissue-engineered therapies reviewed by the Committee for Advanced Therapies.
Priority-medicines support that shapes the dossier long before submission.
The manufacturing story has to hold across sites, scales, and every post-approval change.
Devices, IVDs, and software as a medical device are not filed on the CTD at all. In the US they go to CDRH on device-specific templates; in Europe they earn a CE mark through a notified body under the MDR and IVDR.
The pre-submission program: securing FDA's view on your evidence plan before you build the file.
Premarket notification demonstrating substantial equivalence to a predicate device.
Classification for novel low-to-moderate-risk devices with no predicate.
Premarket Approval, the most evidence-intensive route, for the highest-risk devices.
The Investigational Device Exemption that permits a clinical study to gather that evidence.
Conformity assessment and CE marking through a notified body for medical devices.
The stricter regime for in-vitro diagnostics, which reclassified most IVDs upward.
The Annex II and III technical documentation on which the CE mark is granted.
Device, actor, and unique-device-identifier registration in the EU database.
SaMD and AI-enabled devices carry their own submission expectations on both sides.
Most programs file well past Washington and Amsterdam, and a marketing application is rarely the only submission in play. Each major agency runs its own dossier standard and regional module — most now built on the eCTD backbone — while master files, trial applications, and lifecycle variations run in parallel.
One core dossier, adapted market by market, filed in the order that compounds momentum.
ARTG registration in eCTD, with comparable-overseas-regulator reliance pathways.
NDS / ANDS for drugs and device licences, filed with a Canadian regional module.
The J-NDA in eCTD, with a demanding Japanese Module 1 and bridging-data expectations.
Post-Brexit national filing, with the International Recognition Procedure reusing trusted approvals.
National authorisation in eCTD, often sequenced with the EU file and open to reliance review.
Large markets with distinct dossier, local-testing, and registration rules that reshape the core file.
INDs, CTAs, and EU submissions through CTIS that open and maintain the studies behind the file.
US Drug Master Files and EU Active Substance Master Files that let suppliers support many applications.
Orphan designations, PIPs, and PSPs that carry their own submissions and shape the marketing dossier.
Supplements, variations, and renewals that keep every approval current for the product's life.
Submission quality is built by people who have assembled and defended real dossiers: authored the modules, cleared the validation errors, and answered the reviewer's questions. Your leads are senior regulatory practitioners who have taken NDAs, BLAs, 510(k)s, PMAs, and EU marketing authorisations across the line.
Small molecule, biologic, and device — each filed on its own application, evidence, and format.
We build to the standard of the center or notified body that will actually review the file.
One core dossier engineered to be reshaped for Japan, Canada, Australia, and beyond.
Past the first approval, holding the sequence together across every variation and supplement.
A filing sits at the center of the regulatory program. These are the services submission-stage sponsors reach for most.
The publishing, validation, and gateway transmission that turn authored documents into a compliant electronic submission.
Explore Publishing →The sequencing of markets and procedures so one dossier compounds momentum from the first filing to the next.
Explore Global →Module 3 authored and reconciled so the quality section compiles cleanly into every regional sequence.
Explore CMC →Tell us about your product, your target markets, and your filing timeline. We'll map the submission strategy across FDA, the EU, and beyond, and match you with a senior regulatory lead, with a response within one business day. All inquiries are strictly confidential.
