Life-Sciences AI
AI for discovery, trial, and regulated manufacture.
Yobitel runs AI for biotech, pharma, and CRO/CDMOs — molecular generation, property prediction, clinical-trial design, scientific literature mining, regulatory writing, and GxP manufacturing analytics. Validated for 21 CFR Part 11 with audit-grade lineage for FDA, EMA, and MHRA inspection.
−40%
Hit-to-lead time
+50%
Literature coverage
21 CFR 11
Part-11 validated
GxP-ready
GMP / GLP / GCP
What's hard
The realities of pharma & life sciences AI.
Honest about the constraints. AI in this sector isn't a wrapper on a hosted LLM. It has to land inside your boundary, respect your regulators, and earn the trust of the people on the front line.
Discovery is a search problem at chemical scale
Chemical space is effectively infinite. Brute-force HTS is expensive and biased. Generative models plus property prediction collapse the search to actionable shortlists.
Trial recruitment is the bottleneck
Most pivotal trials miss enrolment milestones. Inclusion / exclusion criteria over real-world EHR + claims data is hard, and consented patient feeds are fragmented.
Scientific evidence outpaces the team
PubMed grows by thousands of papers a day. Without machine reading, regulatory writing and competitive intelligence run weeks behind the field.
Manufacturing is regulated to the molecule
GxP-regulated lines demand validated systems, e-signature, audit trail, and change-control. AI components have to survive inspection without slowing release.
Where AI moves the needle
Six use cases customers ship today.
These aren't demos. Each pattern is in production for at least one customer in this sector. Click through to the underlying Yobitel app, or have us build the custom variant.
Drug discovery (generation + properties)
Molecule generation with property objectives — solubility, ADMET, selectivity — backed by docking and protein-language scoring.
Clinical trial design & matching
Synthetic-control augmentation, eligibility design, and patient matching across EHR / claims under consent — for sponsors and CROs.
Scientific literature mining
Machine reading of PubMed, ClinicalTrials.gov, conference abstracts, patents — surfaces relevant evidence by mechanism and asset.
Regulatory writing copilot
First-draft CSR sections, IB updates, briefing documents, and Module 2 / 3 content with citation rendering and traceable lineage.
Pharmacovigilance & signal detection
Ingests adverse-event narratives, social listening, and case forms; detects safety signals and drafts ICSRs for QPPV review.
GxP manufacturing analytics
Process-analytical technology, batch-record review automation, deviation triage, and OEE for biologics and small-molecule lines.
Featured apps
The Yobitel apps powering Pharma & Life Sciences.
Pre-built, vertical-tuned, observable, and one-click-deployable on the Yobibyte platform. Each link is a deeper drill-in.
MediQuery
Clinical-grade RAG and DDI safety patterns reused for medical-affairs Q&A, MSL field intelligence, and ISS support.
Agentic RAG
Multi-agent retrieval across literature, internal study reports, and regulatory archives. Tool use for ClinicalTrials.gov and PubMed.
LLM Fine-Tuning
Tune on your therapeutic area, your protocols, your CSRs — under GxP-validated training pipelines.
Custom AI Build
Discovery, translational, and manufacturing projects with embedded scientists and engineers experienced in 21 CFR Part 11.
Regulators & frameworks
Built for the audit, not after it.
Compliance isn't a wrapper on top. It's embedded in how we deploy, train, monitor, and prove decisions for pharma & life sciences customers.
21 CFR Part 11
Validated e-signature, hash-chained audit trail, account lifecycle controls, and qualification documentation pack.
GxP — GMP, GLP, GCP
URS / FS / IQ / OQ / PQ artefacts. Validation lifecycle for AI components classified as GAMP 5 category 4 / 5.
FDA, EMA, MHRA, PMDA
Inspection-ready artefacts: model risk file, training-data lineage, version registry, change-control history.
ICH guidelines (E6, E8, E9, M4)
Good Clinical Practice and CTD-Module mapping. eCTD-aware regulatory writing pipeline with reviewer comments tracked.
EMA Reflection Paper on AI
Aligned with the EMA's risk-based approach across the medicinal-product lifecycle, including transparency and human oversight.
GDPR Article 9 + HIPAA
Special-category health data: lawful basis, DPIA, customer-managed keys, in-region residency, right-to-erasure pattern.
How we deploy
The Pharma & Life Sciences deployment pattern.
The shape of every successful pharma & life sciences engagement, refined across years of customer rollouts and grounded in the operational reality of the sector.
- 01
Validate the environment
Qualified compute, immutable model registry, and validated training and inference pipelines under 21 CFR Part 11.
- 02
Ingest the scientific corpus
Internal CSRs, protocols, regulatory submissions, plus PubMed, patents, and ClinicalTrials.gov — versioned and provenance-tracked.
- 03
Reason with grounding
Retrieval-grounded generation with citation rendering; refusal mode when the corpus doesn't support the claim.
- 04
Gate with QA-in-the-loop
Required reviewer sign-off on regulatory output and safety signals. Reviewer comments captured back into the model.
- 05
Inspection-ready by default
Auto-generated pack covering model lineage, training data, validation runs, and post-deployment monitoring for inspection.
Outcomes, measured
The numbers customers put on the slide.
Quantified outcomes from production deployments. Each tied to a real customer, even when the logo is held back at their request.
−40%
Hit-to-lead time
Mid-cap discovery biotech
+50%
Literature coverage
Top-10 pharma medical-affairs
−65%
Regulatory writing first-draft time
Global CRO
−30%
Deviation-triage cycle
Biologics CDMO
Customer story
Mid-cap discovery biotech
Compressed hit-to-lead from 14 months to under 8 on a tough kinase target — with every model decision pinned to a citation.
“Yobitel respected the regulatory reality. The validation pack didn't slow us down, and the model never invented a citation. That's the bar.”
What we delivered
−40%
Hit-to-lead time
+50%
Literature coverage
−65%
Regulatory writing first-draft time
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ExploreReady to ship AI in pharma & life sciences?
Book a working session with Yobitel engineers who've done it before in your sector. Walk away with a concrete deployment plan and an eight-week pilot scope.