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. <