Corverxis Technologies · Life Sciences AI

Accelerate Life Sciences
with Intelligent AI

NexGenLife streamlines every stage of the life sciences journey — from medical device documentation and FDA submissions to drug development, clinical trials, and market launch. Powered by NexGen Ultra.

80%
Faster Doc Generation
ISO 13485
QMS Ready
21 CFR
FDA Compliant
ICH E6
GCP Aligned
Platform Modules
Everything life sciences
needs, in one platform
Six integrated AI modules covering the full product lifecycle — from first-in-human to commercial launch.
🩺
Medical Device Hub
FDA · CE · ISO
AI-generated regulatory documentation for Class I, II, and III medical devices. From Design History Files to 510(k) submissions — fully structured and audit-ready.
510(k), PMA & De Novo submission packages
Design History File (DHF) & Device Master Record
Risk management per ISO 14971
Technical file for CE Marking (EU MDR 2017/745)
Predicate device comparison & substantial equivalence analysis
510(k)
submission ready
📋
FDA Submissions
21 CFR · eCTD
Intelligent eCTD dossier assembly for IND, NDA, BLA, and ANDA submissions. AI drafts, reviews, and structures every section to FDA formatting requirements.
IND, NDA, BLA, ANDA full dossier generation
eCTD module structure (1.0–5.0) auto-assembly
Clinical study reports per ICH E3 template
Labelling & prescribing information drafts
FDA meeting request packages & briefing docs
eCTD
auto-structured
💊
Drug Development
Discovery · IND
From target identification through IND-enabling studies. AI synthesises literature, generates CMC sections, writes pharmacology summaries, and drafts early-phase protocols.
Target product profile (TPP) generation
CMC sections: drug substance, drug product
Pharmacology & toxicology summary writing
IND application package (21 CFR Part 312)
Investigator's Brochure (IB) generation
IND
package ready
🔬
Pre-Clinical Studies
GLP · OECD
GLP-compliant study protocol generation, data analysis, and final study report writing for toxicology, pharmacokinetics, ADME, and safety pharmacology studies.
GLP study protocols (OECD, ICH S-series)
Acute, subacute & chronic toxicology reports
PK/PD modelling summaries & reports
ADME & metabolite identification reports
Genotoxicity, carcinogenicity study reports
GLP
compliant reports
👥
Clinical Trials
GCP · ICH E6
End-to-end clinical trial documentation — from Phase I first-in-human protocols through Phase III pivotal trials and regulatory submission of clinical study reports.
Clinical trial protocol & amendments (ICH E6)
Informed consent forms (ICF) — plain language
Statistical analysis plans (SAP) per ICH E9
Clinical study reports (CSR) per ICH E3
DSMB/IDMC charters & safety reports
Phase I–III
protocols & CSRs
⚙️
Quality Management
ISO 9001 · ISO 13485
AI-powered QMS documentation system covering SOPs, CAPAs, audit management, change control, deviation reports, and product release — aligned to ISO 13485 and cGMP.
SOP & work instruction generation (ISO 13485)
CAPA management & root cause analysis
Audit reports, responses & corrective actions
Change control & validation documentation
Batch records & product release documents
ISO 13485
QMS aligned
🔭
R&D Intelligence
Research · Literature · IND
AI-powered research and development documentation — from hypothesis to publication. Synthesise literature, draft research protocols, generate grant applications, and produce scientific reports aligned to regulatory requirements.
Systematic literature review & meta-analysis reports
Research & development protocols (in-vitro, in-vivo)
Grant applications (NIH, Wellcome Trust, EU Horizon)
Scientific manuscript drafting (IMRaD structure)
Proof-of-concept & feasibility study reports
NIH · EU · WHO
grant-ready formats
⚖️
Patent & IP Documentation
USPTO · EPO · WIPO · PCT
AI-assisted patent drafting and filing for US and international protection. From provisional applications to full PCT filings — NexGen Ultra drafts claims, specifications, and abstracts aligned to USPTO, EPO, and WIPO requirements.
US provisional & non-provisional patent applications (USPTO)
PCT international filing (WIPO) — 157 countries
European patent application (EPO — EPC 2000)
African Regional IP Organisation (ARIPO) filings
Patent claims drafting (independent & dependent)
Freedom-to-operate & prior art search reports
157 countries
PCT coverage
Product Lifecycle
From discovery to
commercial launch
NexGenLife supports every phase of the regulatory and development pipeline with intelligent document generation and compliance tracking.
1
Phase 0 · Discovery
Target Identification & Lead Optimisation
AI synthesis of literature, patent landscaping, target product profiles, and competitive intelligence. Generate research protocols, scientific advisory board briefings, and IP documentation.
Target Product Profile Literature Review Patent Analysis Research Protocols
Months6–18
AI-ASSISTED
2
Phase 1 · Pre-Clinical
GLP Safety & Efficacy Studies
Generate GLP-compliant study protocols, manage study data, write final study reports for toxicology, PK/PD, ADME, and safety pharmacology. Prepare IND-enabling study summaries.
GLP Protocols Tox Reports PK/PD Summary IND Enabling
Months12–24
GLP REQUIRED
3
Phase 2 · IND / CTA Submission
Regulatory Filing — First-in-Human
AI-assembled IND application (21 CFR Part 312) or CTA (EU CTR). Automated eCTD structuring, Investigator's Brochure generation, Phase I protocol writing, and FDA pre-IND meeting package preparation.
IND Application Investigator's Brochure Phase I Protocol eCTD Assembly
Months3–6
FDA SUBMISSION
4
Phase 3 · Clinical Trials
Phase I → Phase III Trial Management
Comprehensive clinical trial documentation for all phases. Protocol design, ICF plain-language writing, CRF design, SAP drafting, interim analyses, DSMB charters, and final CSR writing to ICH E3.
Trial Protocols ICF Writing SAP / CSR DSMB Charter Safety Reports
Years3–7
GCP REQUIRED
5
Phase 4 · NDA / BLA / 510(k) Submission
Marketing Authorisation Application
Full NDA, BLA, ANDA, or 510(k) dossier assembly. AI writes all summary documents, structures the complete eCTD, generates labelling, and prepares advisory committee briefing documents.
NDA / BLA 510(k) Package Labelling Advisory Committee REMS
Months6–24
FDA REVIEW
6
Phase 5 · Commercial Launch
Post-Market Surveillance & Pharmacovigilance
Post-approval change supplements, PSUR/PBRER writing, adverse event reporting, post-market clinical follow-up (PMCF), and annual product quality reviews — all AI-generated and compliance-tracked.
PSUR / PBRER Adverse Events Annual Reports Supplements PMCF
Ongoing
CONTINUOUS
Document Library
Generate any regulatory
document in minutes
60+ document templates covering every format, framework, and regulatory body. Click any document to generate with NexGenLife AI.
Compliance Management
Real-time quality &
submission tracking
Track submission timelines, QMS compliance status, and regulatory milestones across all your programmes in one dashboard.
Active Programmes
Platform Capabilities
Built for regulatory
professionals
Every feature designed with regulatory scientists, clinical operations teams, and quality professionals in mind.
🤖
NexGen Ultra AI
Powered by the most capable NexGen model. Understands ICH guidelines, 21 CFR parts, EU MDR, and ISO standards natively.
📐
Regulatory Templates
60+ pre-built templates aligned to FDA, EMA, PMDA, Health Canada, NAFDAC, and ICH formatting requirements.
🔒
21 CFR Part 11 Ready
Electronic records and signatures compliant with FDA 21 CFR Part 11. Audit trails, version control, and access management.
🔗
eCTD Auto-Assembly
Automatically structures documents into eCTD format (ICH M8) for direct submission to FDA, EMA, and other authorities.
📊
Submission Analytics
Track submission completeness, identify gaps, predict review timelines, and benchmark against historical approval data.
🌍
Multi-Jurisdiction
Simultaneous submissions to FDA, EMA, MHRA, PMDA, Health Canada, TGA, ANVISA, NAFDAC, and more from one platform.
🔄
Version Control
Complete document versioning with change tracking, comparison views, and automated amendment management.
👥
Collaboration
Multi-user editing with role-based permissions, review workflows, e-signature, and comment management.
Pricing
Simple, transparent
life sciences pricing
All plans include access to NexGen Ultra AI for document generation. No per-document fees.
Starter
$490/month
For early-stage biotechs and individual regulatory consultants.
  • 3 active programmes
  • All 6 platform modules
  • 50 document generations/mo
  • eCTD export
  • Email support
  • 21 CFR Part 11 e-signatures
  • Multi-jurisdiction parallel submissions
  • Dedicated regulatory specialist
MOST POPULAR
Professional
$1,490/month
For growing biotech and pharma companies managing multiple programmes.
  • Unlimited programmes
  • All 6 platform modules
  • Unlimited document generation
  • eCTD auto-assembly
  • 21 CFR Part 11 e-signatures
  • Multi-jurisdiction submissions
  • Priority support (24h response)
  • Dedicated regulatory specialist
Enterprise
Custom
For large pharma, CROs, and medical device manufacturers with complex needs.
  • Unlimited everything
  • Private cloud / on-premise deployment
  • Custom AI fine-tuning on your data
  • ERP / LIMS / eTMF integration
  • Dedicated regulatory specialist
  • SLA: 99.99% uptime
  • Custom validation package (CSV/IQ/OQ/PQ)
  • White-label option available
Get Started Today
Ready to accelerate
your time to market?
Join leading biotech and pharma companies using NexGenLife to cut documentation time by 80% and submit faster to FDA, EMA, and global regulators.
Open NexGen Console →
NexGenLife
AI-powered life sciences documentation platform.
Sign in or create your free account to continue.
OR
By continuing you agree to our Terms and Privacy Policy