Readiness Program
FDA PreCheck, the BIOSECURE Act, and CDMO Selection
Know where your manufacturing and clinical supply chain is exposed, how to select CDMOs and CROs under BIOSECURE, and how the FDA PreCheck program changes US facility planning.
Two Policy Shifts, One Sourcing Decision
The BIOSECURE Act pushes companies with US federal exposure to look hard at which contract organizations touch their programs, and at whether a named entity sits anywhere in the chain of manufacture, testing, or data handling. For a clinical stage biotech the practical question is not political. It is whether a partner chosen for speed today becomes a partner you must replace mid development.
At the same time, the FDA PreCheck pilot creates an earlier, more structured route for engaging the agency on domestic manufacturing facilities, well before a license application. Used properly it shortens the distance between a facility decision and a reviewable CMC package. Used late it is simply another meeting.
PXM helps leadership teams read both changes as one sourcing and CMC decision: where the current exposure sits, what a transfer would actually cost in time and comparability work, and which parts of the plan belong in front of FDA now.
What We Deliver
Supply Chain Exposure Review
Mapping of every CDMO, CRO, testing lab, and data processor touching the program, with a clear view of where BIOSECURE style restrictions create real risk rather than headline risk.
CDMO and CRO Selection
Structured selection and diligence against capacity, modality fit, regulatory track record, quality systems, and geography, not just quoted price and timeline.
Transfer and Dual Sourcing Plans
Sequenced tech transfer plans with comparability strategy, analytical bridging, and the regulatory filings each step triggers.
FDA PreCheck Preparation
Assessment of whether the PreCheck route fits your facility plan, and preparation of the facility and process information the agency will expect to discuss.
US Entry Planning for EU and UK Biotechs
Alignment of an existing EU or UK manufacturing footprint with US expectations, including what must move onshore and what does not.
Diligence Support
Independent supply chain and CMC risk assessment for investors, boards, and licensing partners ahead of a financing or transaction.
Who This Is For
- Biotech companies with a current or planned CDMO or CRO relationship that may fall under BIOSECURE style restrictions
- EU and UK companies planning a US clinical program and deciding how much of the supply chain must sit onshore
- Programs weighing a domestic facility investment and considering whether the FDA PreCheck pilot fits their timeline
- Teams facing a tech transfer mid development and needing a comparability and filing strategy that holds up
- Investors and boards asking for an independent read on manufacturing and supply chain concentration risk
How We Work
Map
Build the full picture of who makes, tests, and handles what, including subcontracted steps that rarely appear on a slide.
Assess
Separate genuine regulatory and legislative exposure from noise, and quantify what a change of partner would cost in months and comparability work.
Plan
Define the sourcing decision, the transfer sequence, and the agency engagement plan, including whether PreCheck belongs in it.
Execute
Support selection, transfer oversight, and the CMC filings that follow, through to the next development milestone.
Frequently Asked Questions
Related Reading
Choosing a US CDMO or CRO in 2026
What the BIOSECURE Act and the FDA PreCheck pilot mean for EU biotechs selecting US manufacturing and clinical partners.
Read moreCDMO Selection Criteria for Biotech
The criteria that actually predict a successful partnership, plus a full FAQ on selection, audits, and transfer risk.
Read moreCMC Strategy Mistakes That Delay IND Filings
Where manufacturing and comparability decisions quietly push an IND timeline out by quarters.
Read moreFDA & 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 program?
Speak with a senior PXM operator about your biosecure act & fda precheck readiness strategy.