Regulatory Writing · Expert Reports
Clinical and Nonclinical Expert Reports for EU Marketing Authorisations
A named, independent Clinical Expert and Nonclinical Expert who writes and signs your Clinical Overview (Module 2.5) and Nonclinical Overview (Module 2.4). Expert statement and CV included, as required under Article 12 of Directive 2001/83/EC.
Your signing expert
Neta Kela, PhD
Clinical and Nonclinical Expert · Founder and Managing Partner, PXM
Every PXM Expert Report is written and signed by Neta Kela, PhD. Neta brings a drug development career across biologics, cell therapy, antibody therapeutics and immunology, postdoctoral training at Stanford University and a McCormick Fellowship for Women in Science. She works with European and US sponsors on EU and FDA regulatory strategy and serves as Chief Commercial Partner at the University of Copenhagen. Your dossier gets one accountable expert, not an anonymous writing pool.
Read Neta's full profile →Dossier types we cover
Full marketing authorisation
Clinical Overview (2.5) and Nonclinical Overview (2.4) for complete EU MAAs, critically assessing Modules 4 and 5 and aligned with Module 3.
Hybrid applications (Article 10(3))
Expert Reports that justify the differences from the reference medicinal product (new strength, pharmaceutical form, route or indication) and assess the bridging data that supports them.
Well-established use (Article 10a)
Overviews built on published literature, demonstrating at least ten years of well-established medicinal use in the EU with recognised efficacy and an acceptable level of safety.
Variations
New or updated Expert Reports for Type II variations and line extensions, including new indications and formulation changes.
Need only Module 2.4? Nonclinical Overview (2.4) page. Not sure which legal basis fits? Compare EU regulatory pathways
Pricing
Every engagement is quoted as a fixed fee, scoped against your dossier type and data package. No hourly billing, no surprises.
Single Overview
One signed overview, Clinical (2.5) or Nonclinical (2.4), for a variation or focused dossier.
- Scoped fixed fee
- Expert statement and CV
- One revision round
Clinical + Nonclinical Pair
Both overviews prepared together for a hybrid, well-established use or full application.
- Scoped fixed fee
- Consistent critical assessment across both overviews
- Expert statement and CV for each
- Two revision rounds
Full dossier support
Expert Reports plus gap assessment of the underlying data package before drafting begins.
- Scoped fixed fee
- Data gap assessment
- Both overviews with expert statements and CVs
- Support through agency questions
Who this is for
- Generics and hybrid applicants preparing EU submissions
- Companies pursuing well-established use applications on bibliographic data
- Biotech and pharma teams filing major variations
- Regulatory teams that need an independent signing expert
- Sponsors whose existing expert has left or is no longer independent
How it works
Scope
You share the product, legal basis and data package. We confirm scope, timeline and a fixed fee.
Assess
The signing expert reviews the source data and agrees the critical assessment approach with your team.
Draft
The overview is drafted, reviewed internally, and shared with you for comment.
Sign
The final report is signed, with the expert statement and CV ready for inclusion in the dossier.
Request a quote
Tell us about your product and dossier and we will respond with a scoped, fixed-fee proposal.
Frequently Asked Questions
FDA & CMC Readiness
Guides and insights
What a Clinical Overview Must Contain for an EU Hybrid Application
What the Clinical Overview (Module 2.5) must cover in an EU hybrid application under Article 10(3), how to justify differences from the reference product, and where assessors push back.
Read the guide →Well-Established Use Applications: Building a Bibliographic Clinical Overview That Holds Up
How to build the Clinical Overview for an EU well-established use application under Article 10a: the ten-year test, literature selection, and how to bridge your product to the published evidence.
Read the guide →How to Choose an Independent Clinical Expert for Your EU Dossier
What Article 12 of Directive 2001/83/EC requires from the Clinical and Nonclinical Expert, what to look for when you appoint one, and the questions to ask before they sign.
Read the guide →FDA National Priority Voucher (CNPV): Should You Apply?
What the FDA national priority voucher (CNPV) offers in 2026, how it compares to other expedited programs, and what EU sponsors need ready first.
Read the guide →Your CDMO Just Became a Regulatory Risk: BIOSECURE and FDA PreCheck Explained
The BIOSECURE Act is law and the FDA's PreCheck pilot has named its first participants. Both change how EU biotechs should screen, select, and oversee US CDMOs and CROs.
Read the guide →How to Prepare for an FDA Pre-IND Meeting (and What Most Teams Get Wrong)
A pre-IND meeting is the cheapest regulatory advice a biotech will ever get, and the most commonly wasted. What to ask, what to include in the briefing book, and where teams lose the value.
Read the guide →IND-Enabling Studies: What a First-in-Human Package Actually Requires
What IND-enabling studies are, which ones the FDA expects before first-in-human, how long the package takes, and the sequencing decisions that quietly determine your filing date.
Read the guide →CDMO Selection for Biotech: The Criteria That Actually Predict Success
Choosing a CDMO is a regulatory decision, not a procurement one. The criteria that matter, the questions to ask before signing, and the contract terms teams regret leaving out.
Read the guide →5 CMC Strategy Mistakes That Delay IND Filings — And How to Avoid Them
Common chemistry, manufacturing, and controls pitfalls that quietly derail small biotech IND timelines, and the practical fixes that keep programs on track.
Read the guide →3 Regulatory Mistakes That Keep Coming Up in Biotech
After several recent conversations with biotech and digital health teams, a pattern keeps repeating. Not around the science — that's usually strong. It's around regulation.
Read the guide →Bluebird Bio's Three-Year FDA Delay: The CMC Trap That Stalls Gene Therapy Programs
Bluebird Bio almost didn't survive the road to FDA approval — not because the science wasn't there, but because of CMC comparability gaps and pediatric safety signals that weren't built into the development plan. The same patterns are stalling programs today.
Read the guide →UK Biotech Companies: How to Navigate EU and US Market Entry Post-Brexit
Brexit has fundamentally reshaped the regulatory and commercial landscape for UK biotech companies. Navigating parallel pathways across the MHRA, EMA, and FDA requires a new level of strategic coordination — and the companies that adapt fastest will capture the greatest opportunity.
Read the guide →Cell Therapy Companies: Manufacturing May Become Your Biggest Bottleneck
Many biotech teams focus heavily on discovery and clinical data. But regulators are increasingly asking a different question: Can you manufacture your therapy consistently and at scale?
Read the guide →A Regulatory Inflection Point for Biologics – Will You Lead or React?
The FDA's recent announcement signals a meaningful shift in how biologics and ultra-rare disease therapies may be evaluated — including openness to smaller, well-justified data packages.
Read the guide →
Ready to discuss your dossier?
Speak with PXM about your Clinical and Nonclinical Expert Reports.