SUSAR reports, SAE files, pharmacovigilance documents, ICF, CSR — these are not occasional projects. They are our core daily operation. A dedicated pharma DTP team. 24×7. Every file, every shift.
B2K processes the most regulated, highest-stakes document types in life sciences — every day, at volume, under agreed SLA.
Every file passes through the same five-stage pipeline. Named tools at each step. Four QC gates before delivery.
Every pharma DTP file passes through the same independent four-round quality system that runs across B2K — Paginator Self-Check → Senior Review → QC Review → QA Final Gate. The QA gate is the pharma standards-compliance sign-off. No file is released without it.
Pharma operations are produced under 21 CFR Part 11, EU Annex 11, and ICH standards — on a Sophos-protected infrastructure with named-reviewer RBAC, CCTV, NDA on every operator, audit-ready communications, and zero subcontracting.
B2K is integrating AI tooling into DTP workflows under controlled benchmarking. In life sciences document processing, validated adoption matters more than speed of adoption. Nothing goes live without passing pharma-grade quality benchmarks first.
| Workflow stage | Current production toolchain | AI integration status |
|---|---|---|
| Text extraction from PDF | ABBYY FineReader | In testing |
| Tag cleaning & bilingual prep | TransTools | In testing |
| Layout fixing & formatting | Adobe InDesign · MS Word templates | Scoping phase |
| QA anomaly detection | 4-round manual QC process | In testing |
NDA signed before briefing. Pilot project available. Response within 24 hours.
Start a conversation →Yes. All pharma operations are produced under 21 CFR Part 11, EU Annex 11 and ICH standards, on Sophos-protected infrastructure with named-reviewer RBAC, an NDA on every operator, and audit-ready, time-stamped versioning archived per project.
SUSAR reports, SAE narratives and MedWatch forms, pharmacovigilance files (ICSRs, PSURs, PBRERs), informed consent forms, EC/RA correspondence, Clinical Study Reports to ICH E3, and eCTD-aligned Module 1-5 submissions, as core daily production rather than occasional projects.
No. Every file is handled in-house by a dedicated full-time pharma DTP team under direct quality oversight, with zero subcontracting and an NDA signed before briefing.
A 99.5% monthly SLA on turnaround and quality, with four independent QC rounds per file (paginator self-check, senior review, QC review, QA final gate) and a 5-Why root-cause analysis filed on every exception.
Within 24 hours, with a pilot project available before any full-volume commitment and an NDA signed before briefing.