CMC Regulatory Affairs & Module 3 Support Vendors
Regulatory support for chemistry, manufacturing, and controls content, Module 3 documentation, quality sections, and CMC lifecycle changes.
Related workflows
Consulting / Advisory Firm · +2 more types
Voisin Consulting Life Sciences provides regulatory, clinical, pharmacovigilance, market access and development services.
Evidence-backed capability match
“Accurate assessment and categorization of CMC changes, with the preparation of critical modules like 3 and 2.3.”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
Consulting / Advisory Firm · +2 more types
Halloran Consulting Group is a life-sciences consulting firm providing regulatory strategy, dossier writing, GxP quality, and clinical trial management.
Evidence-backed capability match
“Submission Review: Experienced Reg CMC professionals review regulatory filing documents, providing recommendations to de-risk submissions.”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more
Consulting / Advisory Firm · +1 more type
Tunnell Consulting is a life sciences consulting firm providing GxP compliance, regulatory strategy, and technology transfer support.
Evidence-backed capability match
“Regulatory Submission support including CMC authoring and publishing, PAI readiness assessment, post marketing CMC management including supplements, changes being effected and…”Source: tunnellconsulting.com
Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +2 more
CRO / Research Services Provider · +2 more types
Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.
Products: InStat, CoAuthor
Evidence-backed capability match
“Veristat helps sponsors plan and document CMC programs for Pre-IND, IMPD, clinical development, marketing applications, and post-approval changes across regions.”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Service Provider · +2 more types
ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.
Products: D.AI.M.I.
Evidence-backed capability match
“Authoring quality overall summary (CTD Module 2.3 – QOS) and CTD Module 3 sections for new registration applications (new MAA, NDA/ANDA, BLA)”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
CDMO / CMO · +4 more types
VectorBuilder provides CRO and CDMO services for gene therapy vectors, plasmids, RNA therapeutics, discovery programs, and related testing.
Products: LentiBuilder, CliniVec +1 more
Evidence-backed capability match
“From strategy consultation for IND-enabling documentation to CMC documentation for clinical trial and BLA filing.”Source: en.vectorbuilder.com
Also offers: AAV & Lentiviral Vector Manufacturing, Plasmid DNA Manufacturing, +3 more
CRO / Research Services Provider · +7 more types
IQVIA is a CRO and technology provider delivering clinical trials, real-world evidence, commercial intelligence and safety operations.
Products: IQVIA Vigilance Platform, SmartSolve +4 more
Evidence-backed capability match
“We provide CMC strategy, labeling, and GMP compliance audit support. We also provide Pre-IND and scientific advice meeting consultation. Through an award from the California…”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more
Compare listed vendors
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Halloran Consulting Group | Consulting / Advisory Firm | Regulatory Writing & Dossier Content | “Submission Review: Experienced Reg CMC professionals review regulatory filing documents, providing recommendations to de-risk submissions.”hallorancg.com · reviewed Oct 21, 2026 |
| IQVIA | CRO / Research Services Provider | Regulatory Writing & Dossier Content, Regulatory Labeling & Artwork Compliance | “We provide CMC strategy, labeling, and GMP compliance audit support. We also provide Pre-IND and scientific advice meeting consultation. Through an award from…”iqvia.com · reviewed Oct 19, 2026 |
| ProductLife Group | Service Provider | Regulatory Writing & Dossier Content, Regulatory Labeling & Artwork Compliance | “Authoring quality overall summary (CTD Module 2.3 – QOS) and CTD Module 3 sections for new registration applications (new MAA, NDA/ANDA, BLA)”plglifesciences.com · reviewed Oct 26, 2026 |
| Tunnell Consulting | Consulting / Advisory Firm | Regulatory Writing & Dossier Content | “Regulatory Submission support including CMC authoring and publishing, PAI readiness assessment, post marketing CMC management including supplements, changes…”tunnellconsulting.com · reviewed Oct 21, 2026 |
| VectorBuilder | CDMO / CMO | — | “From strategy consultation for IND-enabling documentation to CMC documentation for clinical trial and BLA filing.”en.vectorbuilder.com · reviewed Oct 28, 2026 |
| Veristat | CRO / Research Services Provider | Regulatory Writing & Dossier Content, Regulatory Labeling & Artwork Compliance | “Veristat helps sponsors plan and document CMC programs for Pre-IND, IMPD, clinical development, marketing applications, and post-approval changes across…”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Regulatory Writing & Dossier Content | “Accurate assessment and categorization of CMC changes, with the preparation of critical modules like 3 and 2.3.”voisinconsulting.com · reviewed Oct 28, 2026 |