CMC documentation for novel modalities
Cell, gene, RNA, peptide, ADC, or radioligand. Module 3 sections built by specialists who have shipped INDs in your modality before, with in-house clinical and regulatory experts reviewing and signing off on every output. Not a generic CMC writer learning your science on your dollar.
Novel modality CMC is where filings get held up
For cell, gene, RNA, ADC, and radioligand programs, FDA's expectations have shifted dramatically over the last 24 months. Generic CMC writers, even very senior ones, produce sections that read like small-molecule documents with the modality name swapped in. Comparability strategies miss what FDA now expects. Specifications are set without a sound process characterization basis.
The sections technically file, but you eat 2–3 rounds of FDA information requests during review. We write the section the agency expects to see for your modality, the first time.
Each engagement is led by someone who has shipped your modality
Autologous and allogeneic, including CAR-T, NK, and TCR-engineered programs.
AAV, lentiviral, and in-vivo gene editing (CRISPR, base, prime).
mRNA, siRNA, ASOs, and circRNA, including LNP-formulated programs.
Cyclic, conjugated, and synthetic peptides incl. GLP-1 class.
DAR characterization, linker chemistry, and payload control strategy.
Radiolabeled small molecules, peptides, and antibodies.
Modular or full IND CMC, your choice
Module 3 / IND CMC sections
Drug substance (S) and drug product (P) sections drafted to eCTD-ready quality. Pick the modules you need or the full set.
Comparability & specifications strategy
Justified specs grounded in process characterization. Comparability strategy for pre- and post-pivotal process changes.
Process characterization summaries
Critical process parameters, critical quality attributes, and the experimental data package supporting them.
FDA Type C / pre-BLA CMC briefing support
CMC-specific FDA meeting prep with briefing book, agreed questions, and mock review session.
CMC writers who have actually built your modality
Modality-matched lead, not a generalist
Each engagement is staffed with a CMC specialist who has hands-on experience in your modality. We won't take a project we can't match this way. Our in-house team reviews and signs off on every output.
Up-to-date with FDA's evolving expectations
Our platform indexes every CMC-related guidance, OTP and OCTGT review precedent, and recent advisory committee discussion. We write to today's expectations, not 2021's.
Modular fixed pricing
Need only the drug substance sections? Only Module 3.2.S.4? Pick the modules. Each has a fixed price. Full IND CMC packages start at $250K, typically half what a CRO charges.
Pressure-test what you have, or have us write it
Pick the on-ramp that fits the milestone. Both come with a fixed-fee SOW in 24 hours.
CMC gap assessment
We review your existing CMC sections against current FDA expectations for your modality and tell you what to fix.
- Section-by-section gap analysis (10–15 pages)
- Comparability and specifications readiness checklist
- Top 5 risks before your next FDA interaction
- 1-hour readout with the modality-matched specialist
Full CMC package
Module 3 sections built from scratch by a modality-matched specialist, reviewed by our in-house team.
- Module 3 / IND CMC sections, eCTD-ready
- Comparability and specifications strategy
- Process characterization summaries
- FDA Type C / pre-BLA CMC briefing support
CMC milestone in the next 90 days?
Send your modality and the modules you need. You'll get a fixed-fee proposal back within one business day, with timeline, fee, and the proposed modality-matched specialist.