IND & CTA Regulatory Application Support Vendors
Compare regulatory partners that prepare IND and CTA packages and other investigational submissions for clinical trial authorization.
Related workflows
Consulting / Advisory Firm · +2 more types
“Author, prepare, and submit appropriate clinical trial applications (CTAs, INDs)”Source: voisinconsulting.com
Also offers: Regulatory Development Strategy & Agency Interactions, Market Access Strategy & Launch Planning, +3 more
Agency · +2 more types
“…IND/CTA Meeting requests and briefing packages Regulatory responses”Source: bioscriptgroup.com
Also offers: Medical Communications Writing, Regulatory Writing & Dossier Content
CRO / Research Services Provider · +2 more types
Products: ClinQuick
“…Pre-IND Support Preparation & submission of pre-IND meeting requests and briefing packages Investigational brochure (IB) authorship Gap analysis & drug development program…”Source: celerion.com
Also offers: First-in-Human (Phase I) Clinical Pharmacology Support, Clinical Trial Bioanalytical & Biomarker Testing, +2 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Our regulatory, drug development, statistical, CMC and non-clinical / medical/safety experts have prepared more than 180 INDs and CTAs in the past five years”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Service Provider · +2 more types
Products: D.AI.M.I.
“Our regulatory experts provide strategic guidance, project management, and regulatory reports to help clients navigate the investigational submission process (IND, IMPD, CTA) and…”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Consulting / Advisory Firm · +4 more types
Products: Lumanity Illuminator, Evidence Illuminator +9 more
“IND readiness and gap assessments: Comprehensive cross-functional reviews (preclinical, CMC, clinical, regulatory) to ensure programs move swiftly from development to approval to…”Source: lumanity.com
Also offers: Market Access Strategy & Launch Planning, Brand Strategy & Positioning, +2 more
Consulting / Advisory Firm · +2 more types
“Halloran can assist in preparing your IND and provide comprehensive lifecycle support from IND to BLA/NDA submission. We review applications to assess the risks and benefits…”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, GxP Compliance Consulting, +2 more
CRO / Research Services Provider · +1 more type
“Full regulatory submissions and dossier preparation to support your clinical trial approvals in Mexico and LATAM.”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more
Consulting / Advisory Firm · +1 more type
“We see the big picture – from translational medicine, protocol development, trial design, PIND/IND strategy to first dose and beyond.”Source: tunnellconsulting.com
Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +2 more
CDMO / CMO · +1 more type
“We can assist in filing INDs (Investigational New Drug Applications), and we are prepared to file a DMF (Drug Master File) at the appropriate time.”Source: ambiopharm.com
Also offers: Integrated CDMO/CMO Services, Peptide API Manufacturing
CRO / Research Services Provider · +3 more types
Products: Acceleration Platform
“We provide full support, from pre-IND meetings to IND assembly, submission, and maintenance.”Source: altasciences.com
Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“…Our program includes a wide range of cell and gene therapy solutions, including regulatory intelligence, regulatory maintenance and lifecycle support, marketing applications…”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more
CRO / Research Services Provider · +5 more types
“Preparation of IND submission-ready documents”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
Compare listed vendors
What this covers: Regulatory support for clinical-trial authorization packages and investigational submissions before or during clinical development.
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| Altasciences | CRO / Research Services Provider | — | “We provide full support, from pre-IND meetings to IND assembly, submission, and maintenance.”altasciences.com · reviewed Oct 21, 2026 |
| Althian Clinical Research | CRO / Research Services Provider | Marketing Authorization & Lifecycle Submission Support | “Full regulatory submissions and dossier preparation to support your clinical trial approvals in Mexico and LATAM.”althian.com · reviewed Oct 14, 2026 |
| AmbioPharm | CDMO / CMO | — | “We can assist in filing INDs (Investigational New Drug Applications), and we are prepared to file a DMF (Drug Master File) at the appropriate time.”ambiopharm.com · reviewed Oct 20, 2026 |
| Bioscript Group | Agency | — | “…IND/CTA Meeting requests and briefing packages Regulatory responses”bioscriptgroup.com · reviewed Oct 25, 2026 |
| Celerion | CRO / Research Services Provider | Marketing Authorization & Lifecycle Submission Support, Regulatory Representation & Local License Holder Services | “Investigational new drug (IND) application submission Clinical trial application (CTA) submission New Drug Application (NDA) submission Abbreviated New Drug…”celerion.com · reviewed Oct 25, 2026 |
| Frontage Laboratories | CRO / Research Services Provider | — | “Preparation of IND submission-ready documents”frontagelab.com · reviewed Oct 21, 2026 |
| Halloran Consulting Group | Consulting / Advisory Firm | Marketing Authorization & Lifecycle Submission Support, Regulatory Representation & Local License Holder Services | “Halloran can assist in preparing your IND and provide comprehensive lifecycle support from IND to BLA/NDA submission. We review applications to assess the…”hallorancg.com · reviewed Oct 24, 2026 |
| IQVIA | CRO / Research Services Provider | Marketing Authorization & Lifecycle Submission Support | “…Our program includes a wide range of cell and gene therapy solutions, including regulatory intelligence, regulatory maintenance and lifecycle support…”iqvia.com · reviewed Oct 25, 2026 |
| Lumanity | Consulting / Advisory Firm | Marketing Authorization & Lifecycle Submission Support | “IND readiness and gap assessments: Comprehensive cross-functional reviews (preclinical, CMC, clinical, regulatory) to ensure programs move swiftly from…”lumanity.com · reviewed Oct 21, 2026 |
| ProductLife Group | Service Provider | Marketing Authorization & Lifecycle Submission Support, Regulatory Representation & Local License Holder Services | “Our regulatory experts provide strategic guidance, project management, and regulatory reports to help clients navigate the investigational submission process…”plglifesciences.com · reviewed Oct 26, 2026 |
| Tunnell Consulting | Consulting / Advisory Firm | Marketing Authorization & Lifecycle Submission Support | “We see the big picture – from translational medicine, protocol development, trial design, PIND/IND strategy to first dose and beyond.”tunnellconsulting.com · reviewed Oct 21, 2026 |
| Veristat | CRO / Research Services Provider | Marketing Authorization & Lifecycle Submission Support, Regulatory Representation & Local License Holder Services | “Our regulatory, drug development, statistical, CMC and non-clinical / medical/safety experts have prepared more than 180 INDs and CTAs in the past five years”veristat.com · reviewed Oct 21, 2026 |
| Voisin Consulting Life Sciences | Consulting / Advisory Firm | Marketing Authorization & Lifecycle Submission Support | “Author, prepare, and submit appropriate clinical trial applications (CTAs, INDs)”voisinconsulting.com · reviewed Oct 26, 2026 |