§ Division 01 — Regulatory & Healthcare

Submission-ready.
Audit-proof.

Clinical documents, regulatory dossiers, and healthcare data handled with the security and precision that FDA, EMA, and PMDA submissions demand.

Engagements

Hundreds of dossiers

Data handling

HIPAA compliant

NDA

Signed at brief

Response

24-hour SLA

Compliance & Standards

Every submission standard. In-house.

eCTD

Electronic CTD

Module 1–5 compilation, lifecycle management, sequence publishing and re-submission support.

ICH

ICH Guidelines

Full alignment with ICH E3, M4, M8 and related guidance documents across all submission types.

HIPAA

Data Privacy

Encrypted transfer, role-based access, no third-party subcontracting, full audit trail per project.

GxP

GxP-Aligned QMS

ISO-aligned quality management with documented SOPs, multi-stage QC, and named senior reviewers.

Secure Workflow

How sensitive data moves through B2K.

From receipt to submission — every handoff logged, every file encrypted, every reviewer named.

Secure Receipt

Client uploads via encrypted SFTP or secure portal. NDA signed before any file transfer. Access restricted to named project team only.

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QC & Intake

Senior specialist reviews source files. Document inventory created. Scope confirmed against brief. Issues flagged before production begins.

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Production

Dedicated in-house team processes documents per agreed spec. No subcontracting. Full version control and audit trail throughout.

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Multi-Stage QA

Independent QC pass by a reviewer not involved in production. Automated pre-flight checks against agency requirements. Sign-off documented.

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Secure Delivery

Final files delivered via encrypted channel with delivery certificate. Source files purged per agreed data retention policy. Audit trail archived.

ISO-aligned QMS · No subcontracting · Full audit trail

Service Detail

What we deliver.

eCTD Compilation & Lifecycle Management

Module 1–5 preparation, variation submissions, renewal sequences, and response-to-query dossiers formatted for all major regulatory markets.

FDA 21 CFREMAPMDATGAHealth Canada

Clinical Study Reports

CSR formatting, data listings, appendix preparation, and ICH E3-compliant structure for Phase I–IV studies across all therapeutic areas.

ICH E3ListingsAppendicesVeeva Vault

Medical Transcription & Coding

HIPAA-compliant transcription of clinical notes, discharge summaries, and radiology reports. ICD-10/CPT coding, AR follow-up, and denial management.

HIPAAICD-10CPTHL7

Medical Writing Support

Protocol summaries, investigator brochures, patient narratives, SmPCs, and PILs prepared to agency-specific formatting requirements.

SmPCPILIBICF

FAQ

Frequently asked questions

Which regulatory markets and submission standards does B2K support?

eCTD v3.2.2 and v4.0 compilation and lifecycle management for FDA (21 CFR), EMA, PMDA, TGA and Health Canada, fully aligned to ICH E3, M4 and M8 guidance.

Can B2K handle the full eCTD lifecycle, not just initial submissions?

Yes. B2K covers Module 1-5 preparation, variation submissions, renewal sequences and response-to-query dossiers, with sequence publishing and re-submission support.

How does B2K secure sensitive regulatory data?

Encrypted SFTP or secure-portal transfer, an NDA before any file moves, role-based access limited to the named project team, a full audit trail per project, and source files purged per the agreed retention policy after delivery.

Does B2K provide medical writing support alongside publishing?

Yes. B2K prepares protocol summaries, investigator brochures, patient narratives, SmPCs and PILs to agency-specific formatting requirements.

What is B2K's turnaround commitment for regulatory work?

An NDA signed before briefing and a response within 24 hours, with a pilot available before full volume.

Submission-ready.Audit-proof.