CTD module packs assembled to ICH M4 with statistics and citations traceable to source, surveillance feeds that watch PubMed and Europe PMC for your product area, and ALCOA+ QC on every document. Your qualified RA lead signs — that is the point.
Structure from the ICH tree; drafted content only where you supply it; everything else marked TODO with an authoring note. Cross-references checked by code.
Weekly PubMed monitoring with Europe PMC fallback, RA relevance filters, DOI-linked evidence matrices for IB/RIM assembly. Never a partial deliverable.
Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available — scored per document with a PASS/REVIEW verdict at 95%.
Every deliverable carries the human-of-record field; regulatory responsibility stays where the law puts it.
Unsupplied clinical content stays TODO. Invention is a kill-flag offense for agents here.
Every citation carries PMID/DOI and an as-of date; untraceable claims are refused.
| Service | Model | Price |
|---|---|---|
| Module skeleton + gap list (one CTD module) | one-off, 48 h | CHF 0 |
| CTD module pack (drafted from your content) | per module | CHF 2,400 |
| Surveillance feed (topic, weekly) | monthly, cancel monthly | CHF 300 |
| ALCOA+ QC per document | per doc | CHF 400 |
All prices in CHF, excl. VAT where applicable. Swiss QR-bill, net 14 days. Packs include one revision round after your signatory's comments.
A named person replies within 1 business day. The skeleton returns within 48 hours of receiving your module choice.
One CTD module of your choice: full ICH M4 structure with section-level TODO markers and an authoring note per gap — enough to size the work before buying the pack.
No. We draft structure, statistics from supplied data, and citations from traceable sources. Clinical interpretation belongs to your qualified signatory.
Swissmedic, EMA and FDA signals via literature surveillance; the feed is scoped to your product area with relevance filters you approve.
Nine ALCOA+ attributes, pass/fail each, verdict PASS at ≥95% with the failing attributes listed — the checklist ships with the score.