Readiness Program
IND Enabling Readiness for Biotech Programs
Senior operators who design and execute the regulatory, nonclinical, and CMC roadmap that gets your program to a successful IND filing, and a confident first-in-human study.
From Discovery to First-in-Human
The IND-enabling phase is where biotech programs either build the foundation for clinical success or accumulate the gaps that derail first-in-human filings. Decisions made here, on species selection, dose justification, GLP toxicology design, CMC scope, and pre-IND interactions, directly determine whether the FDA places your study on clinical hold.
PXM's senior operators have led IND-enabling programs across small molecules, biologics, cell and gene therapies, and ADCs. We work alongside founders, CSOs, and program leads to define a defensible regulatory strategy, anticipate FDA expectations, and align nonclinical, CMC, and clinical workstreams against a single, coherent IND-readiness plan.
Whether you are 18 months from filing or preparing for a pre-IND meeting next quarter, we provide the executive-level perspective that turns regulatory risk into a managed program timeline.
What We Deliver
IND Strategy & Roadmap
A staged plan covering nonclinical, CMC, clinical, and regulatory deliverables with clear ownership, decision gates, and FDA touchpoints.
Pre-IND Meeting Preparation
Briefing book authoring, question framing, and rehearsal to maximize the value of your FDA pre-IND interaction.
Nonclinical Package Design
Species selection, GLP toxicology study design, safety pharmacology, and ADME strategy aligned with ICH and FDA expectations.
CMC Readiness Alignment
Coordinated CMC strategy ensuring drug substance, drug product, and analytical readiness match clinical timelines.
IND Module Authoring Support
Strategic input and senior review across Modules 2, 3, 4, and 5 to ensure regulatory coherence and reviewer-ready quality.
Risk & Hold Mitigation
Independent regulatory risk assessment to surface and resolve issues that commonly trigger clinical holds before filing.
Who This Is For
- Seed to Series B biotech companies preparing for their first IND filing
- Spin-outs from academic institutions translating preclinical assets toward the clinic
- Program leads facing a pre-IND meeting and needing senior strategic preparation
- Companies that have received FDA feedback and need to recalibrate their IND-enabling plan
- Investors and boards seeking independent diligence on a portfolio company's IND readiness
How We Work
Diagnostic
Rapid assessment of your current program, regulatory posture, and gaps against IND filing requirements.
Strategy
Definition of the IND-enabling roadmap, FDA engagement plan, and integrated nonclinical / CMC / clinical sequencing.
Execution
Senior oversight of pre-IND preparation, study design reviews, vendor selection, and module authoring.
Filing
Final IND review, regulatory risk audit, and post-submission FDA interaction support through 30-day safe harbor.
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 program?
Speak with a senior PXM operator about your ind-enabling regulatory strategy strategy.