Regulatory & Submissions · IND Support
IND Submission Support — CMC and Quality
The short answer
For an IND, the section that most often holds up a program is CMC. We build the chemistry, manufacturing and controls content and the GMP framework behind it — clinical supply manufacturing, specifications, stability and the quality oversight of contract manufacturers — so the information filed reflects a process that can actually be run.
Why this matters
- Clinical supply is manufactured under GMP appropriate to the phase. Sponsors who treat early GMP as optional pay for it at the end of Phase 2.
- Specifications and analytical methods set in the IND carry forward. Loose early specifications become comparability problems later.
- Most sponsors do not manufacture. Oversight of the CMO is the sponsor's obligation and is frequently thin.
Applicable regulations and standards
- 21 CFR 312.23(a)(7)
- CMC information required in the IND.
- FDA Guidance — CGMP for Phase 1 Investigational Drugs
- Phase-appropriate GMP expectations for early clinical supply.
- ICH Q7 / Q8 / Q9 / Q10
- API GMP, development, risk management and quality system expectations.
- 21 CFR Part 211
- cGMP applied as the program moves beyond Phase 1.
What our consultants actually do
- Draft or review drug substance and drug product CMC sections
- Define phase-appropriate specifications, analytical methods and stability protocols
- Build the sponsor quality system: batch release, deviation handling, change control, quality agreements
- Assess and oversee CMOs and CTLs — audits, person-in-plant, batch record review
- Prepare CMC content for pre-IND and Type B meeting packages
- Plan the GMP maturity path from Phase 1 through commercial readiness
Across the product lifecycle
01 / DEVELOP
Process and analytical understanding captured in a form the IND can cite.
02 / SCALE
Clinical supply scale defined with controls that will survive scale-up.
03 / TRANSFER
Method and process transfer to the CMO documented.
04 / VALIDATE
Phase-appropriate qualification; full validation staged for later.
05 / MANUFACTURE
Clinical batches released against defined specifications.
06 / MAINTAIN
Amendments as the process, site or specifications change.
Problems we are usually called about
- Specifications set without a data basis, then tightened or loosened without justification
- Analytical methods used for release that were never qualified
- No sponsor-side batch record review of CMO manufacturing
- Stability program started late, constraining shelf-life claims
- Development data not documented well enough to support later process validation
Typical deliverables
- CMC sections for the IND and subsequent amendments
- Phase-appropriate specification and stability strategy
- Sponsor quality system procedures and quality agreements
- CMO audit reports and oversight plan
- GMP readiness roadmap by clinical phase
Frequently asked
- How much GMP is required for Phase 1?
- Enough to assure identity, quality, purity and strength — documented, controlled and traceable — without the full commercial apparatus. FDA's Phase 1 guidance is explicit that a formal validation program is not expected at that stage, but control and documentation are.
- Do you handle the clinical and nonclinical sections too?
- Our contribution is CMC, manufacturing and quality. Sponsors needing a full submission team including nonclinical and clinical authorship are usually better served by GlobalRegulatory.com, and we work alongside them.
References
More for regulatory & submissions
Technical, manufacturing and quality support for US FDA submissions — written by people who have reviewed and inspected against them.
- 510(k) SupportA 510(k) is an argument for substantial equivalence, supported by evidence your quality system has to be able to produce on demand.
- PMA SupportA PMA is reviewed alongside a pre-approval inspection of the manufacturing site, which means the manufacturing section is not paperwork — it is a description of a facility that will be examined.
- De Novo SupportA De Novo asks FDA to create a classification, which means the submission has to propose the controls that will make the device type safe and effective.
- NDA SupportBy NDA, the manufacturing story has to be complete: a justified control strategy, validated process, qualified methods and a site that can demonstrate all of it during a pre-approval inspection.
- ANDA SupportGeneric applications are decided as much on manufacturing quality and data credibility as on bioequivalence.
- BLA SupportFor a biologic, the process is a substantial part of the product.
- IDE SupportAn IDE requires a description of how the investigational device is made and controlled, and design controls apply even though the device is not yet cleared.
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