Regulatory intelligence for biotechs that outsource everything.
Every partner site, lane, agreement, risk assessment and inspection your programs depend on, held in one governed record.
logxP: the GxP log of everything your partners make, test, store and ship for you.
Program 021, monoclonal antibody. A fictional network. No real companies.
Sites and Coverage status:
Lanes and Lane qualification status:
Inspection: a mock inspection is active at the fill-finish CDMO, North Carolina, US.
Exposure (Roadmap): Programs 021 and 034 depend on the fill-finish CDMO, North Carolina, US, through lanes 1, 3, 4 and 6.
Program 008, oral tablet. A fictional network. No real companies.
Sites and Coverage status:
Lanes and Lane qualification status:
Inspection: no inspection is active on this network.
Exposure (Roadmap): Program 008 depends on the API CDMO, Italy, through lanes 3 and 4.
Entity-of-concern review (Roadmap): regulatory starting material supplier B, Asia.
Program 017, autologous CAR-T. A fictional network. No real companies.
Sites and Coverage status:
Lanes and Lane qualification status:
Inspection: a mock inspection is active at the cell processing CDMO, New Jersey, US.
Exposure (Roadmap): Program 017 depends on the cell processing CDMO, New Jersey, US, through lanes 1, 2, 3 and 4.
Program 029, autologous gene-modified stem cells. A fictional network. No real companies.
Sites and Coverage status:
Lanes and Lane qualification status:
Inspection: no inspection is active on this network.
Exposure: not drawn for this network (Roadmap).
Collection cycles for patient P-0417, 3 batches, 2 CDMOs:
Chain of identity across sites: Roadmap.
Lane key
When everything is outsourced, the record of your supply chain is not yours. It sits in partner portals, inboxes, spreadsheets and the memory of two or three people. Regulators still hold you responsible for all of it.
One contract fill-finish site. At least four FDA refusals to approve, across three sponsors, in 2025.1
74% of FDA complete response letters issued 2020-2024 cited quality or manufacturing issues.2
ICH E6(R3): the sponsor can delegate trial activities to service providers but stays accountable for overseeing them.3
Ask Gene about your own agreements, for example the deviation-notification term in a quality agreement.
Validation studies, equipment qualification and periodic review screens; a frozen PDF of each signed assessment.
Answers linked directly to the governing agreement and lane assessment; an inspector space with token access and no inspector account; dossier export.
Proposes annotations for your team to approve.
This source is not in Gene's library, so Gene will not answer from memory.
Exposure to entity-of-concern rules and tariffs mapped onto your network.
ICH E6(R3) says it about your partners.3 logxP applies the same rule to AI.
Reads partner documents and regulations; proposes annotations, gaps and follow-ups, with sources.
Proposing annotations · In buildQA, RA, supply chain and CMC accept, edit or reject each proposal, and sign what matters.
Named signatures with multi-factor check · LiveWho proposed, who approved, when, and what changed, in an append-only record built on GxP data-integrity principles (ALCOA+).
Audit trail · LiveGene never signs, approves or closes anything.
AI does the reading, so a small team can run the oversight of a much larger quality organisation. The decisions stay with people. The record stays with you.
| Loop step | Gene does | Your team does | logxP records |
|---|---|---|---|
| Annotate | Reads a quality agreement and proposes which sites, lanes and terms it coversIn build | Accepts, edits or rejects each proposal | The proposal, the decision, who and when |
| Validate | Checks coverage gaps and cites the rule behind each oneLive: citations | Reviews and signs the assessmentLive | The signed, versioned record |
| Improve | Drafts the follow-up: renewal, deviation, question for the partnerRoadmap | Approves what changes in the record | Values before and after |
| Repeat | Watches expiries, changes and inspection findingsLive: expiry alerts | Owns the next decision | The full history, kept |
Your fill-finish CDMO emails: FDA investigators arrived this morning.
logxP shows what governs that site: the quality agreement expires in 41 days, the GMP certificate is current, the lane assessments are approved.
logxP traces what depends on it: two programs, four lanes and one pending application.
Your Head of RA opens an inspection event for the site and invites the CDMO's QA lead through a one-time link.
Gene answers a question on QP batch certification for product filled at a third-country site, citing the EU source it holds.
A deviation assessment opens for the drug substance lane to your backup filler.
Gene proposes the quality agreement clauses that cover inspection notification. Your QA lead approves two and rejects one.
A second-site readiness record and an oversight evidence pack are filed for the fill-finish partner.
Every step marked Live works today. Steps marked In build and Roadmap are on the way.
Small molecule
Biologics
mRNA
Radiopharmaceuticals
Autologous ATMP
Allogeneic ATMP
Not a QMS, not an ERP, not a trial supply system, not a shipment tracker. logxP is the record they all hang on.
Outsourced biotechs from Phase 2 to first launch, working with at least three manufacturing, testing or logistics partners.
Your network modelled with you; a mock inspection run on your real record; direct influence on the roadmap order.
Time with your RA, quality or supply chain lead.
You will choose a time and tell us your stage, modalities and number of outsourced partners.
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