TekiReg
AI-generated CTD dossiers — and the launch pipeline that feeds them.
Launches don't stall on the science — they stall on the submission
CTD submissions are still built by hand: unstructured source documents, assembled section by section, with no governance trail.
Source Documents In
No two source documents are structured the same — mostly scans, in mixed formats and templates.
Pages Out
One prescribed CTD structure, aggregated by hand — section by section, value by value.
Per Submission
The filing date is set by document assembly, not by the science — and every product repeats it.
No Governance Trail
Reviews and approvals run over email and shared folders — no version control, no traceability, no audit trail.
A holistic AI system across the CTD process chain
AI Knowledge Assistant
Retrieves, interprets and explains CTD requirements from the knowledge base through a conversational interface — every answer traced back to its source.
AI CTD Generator
Reads and OCRs the scanned source documents, then auto-drafts every section in ICH-compliant structure — straight from the ingested source files.
AI CTD Reviewer
Automated quality control — checks completeness, compliance, formatting and data consistency before a human ever opens the section.
Nothing files without a human signature
Generation & AI Quality Control
Source documents ingested, section auto-drafted in ICH structure, then the AI Reviewer runs completeness, compliance, formatting and consistency checks.
Specialist Review & Sign-off
Section-level specialist review and Regulatory Affairs approval — every version locked, timestamped and audit-logged.
NPS — Objective Product Selection
Sequential Medical → IP → R&D → Regulatory review, closed by a committee Go / No-Go decision with a named owner.
NPD — Execution & Forecasting
Live project visibility and configurable multi-level approval chains — product data flows straight into the CTD knowledge base, no re-entry.
Supply Chain & Procurement
Every material linked to its primary and secondary supplier, with order timing planned around real lead times.
Regulatory Pricing & Portfolio
MOH/EDA pricing rules auto-calculated with full change history, plus five live portfolio views — always current, no manual exports.
The numbers behind the shift
Sections are drafted from the knowledge base instead of assembled by hand — cutting the generation lifecycle by no less than 40%.
Automated completeness, compliance, formatting and consistency checks replace manual page-by-page QC.
McKinsey's estimated value of a faster submission for a $1 billion peak-sales asset, through extended exclusivity.
Sources: McKinsey — Rewiring pharma's regulatory submissions with AI and zero-based design (mckinsey.com) · McKinsey — Generative AI in the pharmaceutical industry: moving from hype to reality (mckinsey.com) · AI-driven automation in eCTD submissions (ijsrtjournal.com)
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