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.
Biologics / CGT Strategy Sprint
Typical range: $5,000–$15,000
For teams that need a credible regulatory plan: product classification, early FDA engagement, and an evidence roadmap.
- 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
Typical range: $8,000–$25,000
For sponsors who need FDA feedback before locking CMC plans, nonclinical packages, or protocol design.
- Briefing package authoring + question strategy
- CMC summary framing (process, controls, comparability plan)
- Meeting prep + minutes + action plan after feedback
CMC Readiness & Documentation Pack
Typical range: $12,000–$45,000+
For teams that need IND-ready CMC narrative and documentation structure—without building a bloated system.
- 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
Typical range: $25,000–$120,000+
For full IND assembly: Module-ready authoring support, consistency checks, and hold-risk reduction.
- IND authoring support across key sections (CMC, nonclinical, clinical)
- Protocol/IB support and safety narrative alignment
- Deficiency/hold response support with document control
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. We help you decide when it's worth the timeline investment.
How early should we engage you?
Ideally before locking your CMC process, nonclinical package, or protocol. Early framing prevents expensive rework and holds.
Are these pricing ranges fixed?
No—these 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.