Clinical & Marketing Applications
Compare vendors for clinical & marketing applications within Regulatory Affairs & Submissions, covering IND & CTA Regulatory Application Support, Marketing Authorization & Lifecycle Submission Support, Regulatory Representation & Local License Holder Services.
Capabilities in this workflow
Vendors supporting this workflow
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
Service Provider · +2 more types
Products: D.AI.M.I.
“End-to-end lifecycle maintenance submissions (renewals, variations – Type I/II, CBE/CB30/PAS, Marketing Authorization Transfers, Line Extensions, PSURs)”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +5 more
CRO / Research Services Provider · +1 more type
“We prepare and submit complete registration dossiers for new products entering the Mexican market, managing the full COFEPRIS review process through to marketing authorization.”Source: althian.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), End-to-End Pharmacovigilance Outsourcing, +2 more
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
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
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 · +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
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
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
Consulting / Advisory Firm · +2 more types
“…APAC Regulatory Support The Value of RookQS Global Regulatory Support Expert Navigation of Global Regulations – By virtue of working in so many different markets, RookQS fully…”Source: rookqs.com
Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs, +1 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 · +5 more types
“Preparation of IND submission-ready documents”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more