IND Strategy, CMC Readiness & FDA Meetings | Built for Modern Modalities
We support biologics, cell & gene therapies, and advanced therapeutics with practical regulatory strategy: pre-IND/INTERACT planning, CMC documentation readiness, protocol support, FDA meeting preparation, and IND builds that reduce avoidable clinical holds.
Why Biologics & Gene Therapy Pathways Break
For advanced modalities, the biggest risk is not "paperwork"—it's misalignment between your product, process, and evidence. Clinical holds often stem from CMC gaps (identity/potency, comparability, controls), unclear starting material traceability, insufficient safety packages, or protocols that don't match your mechanism and risk profile. We help you build a coherent, reviewable story that links CMC controls to clinical safety.
- CMC is the engine: identity, potency, impurities, and process controls must be defensible and documented.
- Traceability & chain-of-custody: starting materials, donors, vectors, and critical reagents need clarity.
- Comparability & change control: process changes must be planned for (and justified) early.
- Clinical alignment: protocol, endpoints, and monitoring must match risks and mechanism of action.
Biologics & Gene Therapy Programs
Structured support for advanced modalities—strategy, documentation, and submission execution. Fees quoted as "from" reflect a minimum scope and are confirmed in writing after triage.
Biologics / CGT Strategy Sprint
For teams that need a credible regulatory plan: product classification, early FDA engagement, and an evidence roadmap.
- Regulatory Strategy & FDA Engagement Plan$12,500
- Development-stage gap read (narrower scope)$7,500
- Regulatory pathway & FDA engagement plan (meeting strategy + timelines)
- High-level CMC and nonclinical gap assessment
- Clinical strategy alignment: endpoints, safety monitoring, risk framing
Pre-IND / INTERACT Meeting Package
For sponsors who need FDA feedback before locking CMC plans, nonclinical packages, or protocol design.
- Pre-IND meeting package (Type B)$18,500–$32,500
- INTERACT meeting package$15,000–$25,000
- Meeting prep + minutes only (package authored by you)$8,500
- Briefing package authoring + question strategy
- CMC summary framing (process, controls, comparability plan)
- Meeting prep + minutes + action plan after feedback
CMC Readiness & Documentation Pack
For teams that need IND-ready CMC narrative and documentation structure—without building a bloated system.
- Full CMC readiness pack (CGT)$45,000–$85,000
- Full CMC readiness pack (recombinant protein / mAb)$32,500–$55,000
- CMC gap assessment only$15,000
- Comparability / change-control plan (standalone)$18,500
- CMC narrative development (identity, potency, impurities, release strategy)
- Process description + control strategy + critical quality attributes (CQA) mapping
- Comparability/change-control planning and vendor/CDMO alignment
IND Build & Submission Support
For full IND assembly: Module-ready authoring support, consistency checks, and hold-risk reduction.
- IND build — biologic (recombinant protein / mAb)from $85,000
- IND build — cell or gene therapyfrom $125,000
- Single-module authoring support$25,000–$55,000
- Clinical hold / deficiency response$18,500–$45,000
- IND annual report$9,500
- IND authoring support across key sections (CMC, nonclinical, clinical)
- Protocol/IB support and safety narrative alignment
- Deficiency/hold response support with document control
How the team is assembled
Verus FDA leads regulatory strategy, FDA engagement, submission architecture, and document control. CMC, nonclinical, and clinical content for advanced modalities is authored with modality-specific subject matter experts brought into the engagement, and that composition is named in the proposal before you sign. You will always know who is writing what.
Start async (preferred for scoping)
Share your modality, construct or cell type, manufacturing arrangement (in-house vs CDMO), current nonclinical package, and target IND date. We'll respond with a scoped plan and a read on the fastest credible route to FDA.
• Fee schedule effective October 1, 2026 (FY2027). Existing clients are held at prior-year pricing through their next renewal.
• Fees are for consulting services and document preparation. FDA fees, analytical and release testing, tox studies, CDMO costs, and clinical trial expenses are billed at cost and are separate.
• Final scope depends on modality, CMC complexity, clinical scope, and current documentation maturity. After triage, we provide a fixed or milestone quote.
• We do not generate analytical data, potency assay results, or tox findings. Those come from your labs and CDMO; we define, structure, and package them.
Who We Help
Cell & Gene Therapy Sponsors
Programs needing coherent control strategies, potency/identity logic, and comparability planning early.
Biologics & Advanced Therapeutics
Novel biologics where CMC narrative quality is the difference between momentum and a preventable hold.
CDMO-Dependent Teams
Sponsors coordinating multiple vendors who need clear responsibilities, data flows, and change control discipline.
Academic Spinouts
Teams translating early research into IND-ready documentation, protocols, and FDA engagement plans.
VC/Partner Diligence
Programs needing a credible FDA plan and evidence roadmap that withstands diligence and deal timelines.
Hold / Deficiency Recovery
Sponsors who received FDA questions and need structured responses that close gaps without creating new ones.
How We Run Biologics & Gene Therapy Engagements
Tight framing, CMC discipline, and meeting-ready documentation from day one.
Product + Risk Profile
We align mechanism, patient population, and risks to an FDA engagement plan and a realistic development sequence.
CMC Control Strategy
We define CQAs, potency/identity logic, release strategy, and change control so the program can scale without breaking.
Nonclinical + Clinical
We align tox, biodistribution (where applicable), monitoring, and endpoints with your risk profile and CMC realities.
IND + Lifecycle
We assemble the submission, manage consistency across sections, and support responses through FDA questions and updates.
Biologics & Gene Therapy FAQs
What's the fastest way to reduce clinical hold risk?
Tight CMC fundamentals (identity/potency, impurities, release, controls), a coherent comparability plan, and a protocol that matches the risk profile. We focus there first because it prevents the most common (and most expensive) delays.
Do we need a pre-IND meeting?
Not always mandatory, but often smart for novel modalities or when CMC/nonclinical strategy needs alignment. There is no FDA fee for the meeting itself, so the cost is the briefing package. We help you decide when it's worth the timeline investment—and INTERACT is often the better first step for very early programs.
Why does a CGT IND cost more than a protein IND?
The CMC module carries far more. Vector and cell bank characterization, potency assay justification, starting material and donor traceability, and comparability across a process that is still changing all sit in a CGT IND and largely do not exist for a well-characterized recombinant protein. The nonclinical package is usually heavier too.
Who actually writes the CMC sections?
Verus leads regulatory strategy, submission architecture, and document control; modality-specific CMC and nonclinical content is authored with subject matter experts named in your proposal before you sign. We would rather show you the team than imply one person covers vector characterization, tox, and clinical protocol design.
Is the strategy sprint fee credited if we move forward?
Yes—credited in full against a Pre-IND or IND engagement opened within 90 days.
Are these pricing ranges fixed?
The single-price items are fixed. The ranges are typical working bands—after a triage call we provide a fixed or milestone quote based on modality, CMC complexity, clinical scope, and current documentation maturity.