Regulatory filing

Getting a medicine approved isn’t just about the science. It’s about knowing how to tell the story clearly, compliantly and convincingly. Regulatory filing is where all the data comes together—and where strategy and execution must align.

At KLIFO, we support pharma and biotech companies in planning, preparing and submitting regulatory filings. Whether you’re working on a Marketing Authorisation Application (MAA) , a New Drug Application (NDA) or a Biologics License Application (BLA), we help ensure your dossier is complete, consistent and submission-ready.

Talk to an expert

Contact our consultants

What is regulatory filing?

A regulatory filing is the process of compiling all relevant regional and scientific data about a medicinal product into a structured dossier and submitting it to health authorities to obtain marketing authorisation. Today, this process is digital using the eCTD (electronic Common Technical Document) format and subject to increasingly complex technical requirements.

KLIFO helps clients not only understand what’s required but deliver it. We combine strategic insight with hands-on document writing and review, regulatory project management including interactions with agencies across regions.

From data to approval: what a successful filing requires

Filing a license application is not just an administrative task. It’s a highly strategic task and a critical milestone that determines the success or delay of your market access. Authorities expect well-structured submissions with coherent narratives and correct formatting.

**What’s inside a regulatory filing?**

Marketing authorisation applications (MAA, NDA, BLA) follow a globally standardised format known as the Common Technical Document (CTD).

The CTD consists of five modules. Module 1 is region-specific, while Modules 2 to 5 — covering quality, non-clinical and clinical data — follow a common format used across all major markets.

KLIFO helps ensure that every element of your dossier fits this structure, with consistent, compliant content that is ready for regulatory review.

Guidance through every phase

Regulatory filing is one of the most critical milestones on the path to market. But it’s only one step in a longer process.

Use the map to explore how submissions connect to earlier development phases — and how KLIFO supports you from first strategy to post-approval compliance.

End-to-end support from planning to submission

KLIFO provides comprehensive support throughout the regulatory filing process — from defining the submission strategy and coordinating dossier content to compiling and submitting the final MAA or BLA/NDA.

As part of the submission process, we ensure your dossier meets the technical standards of the eCTD format and reflects current regulatory guidance — including the correct structure, formatting and navigability required by agencies such as FDA and EMA.

Our regulatory filing services include:
– Gap analysis of current documentation vs. regional requirements
– Submission planning with defined timelines and deliverables
– Compilation and formatting of the regulatory dossier in eCTD
– Review of content for consistency, clarity and traceability (“red line” through the dossier)
– Guidance on submission strategy and procedure selection
– Interaction with authorities (pre-submission meetings)
– Support during the review phase, including handling agency questions

We often support small and mid-sized biotech companies who either lack in-house regulatory capacity or need regional expertise to navigate FDA or EMA procedures. Whether you’re preparing your first NDA or updating a legacy MAA for re-submission, we adapt to your needs and fill the exact gaps that matter.

Whether your product is heading for FDA, EMA or local authorities, we ensure that your submission is both compliant and compelling.

Regulatory strategies tailored to your asset

No two products and no two filings are the same. KLIFO provides tailored regulatory support based on your asset’s therapeutic area and target markets. This includes:

Strategic advice on optimal timing and sequencing of submissions
Country-specific requirement mapping and adaptation
Cross-functional coordination with clinical, nonclinical and CMC experts

We don’t just help you meet requirements. We help you demonstrate value.

Plan yout next submission with us

Why companies choose KLIFO

KLIFO is a consultancy built around highly experienced professionals — people who understand both the technical, operational and strategic dimensions of regulatory filings. Our clients experience us as embedded partners who flex to fit their needs and bring clarity to complex submissions.

KLIFO brings together what most consultancies separate: strategic insight and operational execution — delivered by experienced professionals who understand how to turn potential into approval.

You’ll feel the difference in how we work:

Let’s talk about your next submission

If you’re preparing for a regulatory filing or unsure what’s needed to move forward, KLIFO can help. Our experts are ready to step in wherever you need them most: early planning, gap assessment, document review or full submission management.

We help your product get all the way to patients.

Get in touch to discuss your regulatory submission.

Let’s talk

Regulatory filing