Draft from approved evidence
Build submissions and responses from the tables, analyses, and prior filings the company already approved, with the source behind every statement.
For Regulatory Teams
From Approved Evidence to Submission
Enjamb drafts, checks, and tracks regulatory work from the evidence and filings your company already approved, with every claim linked to source.
Move from new guidance to a submitted, sourced response.
Check consistency across modules
Compare claims, terminology, and data across modules and prior filings, so differences surface before review.
Track every commitment
Keep agency commitments connected to their owners, due dates, and the work that answers them.
How regulatory teams use Enjamb
Regulatory intelligence
Review new guidance, compare it with current policy and program plans, and prepare a cited impact summary.
Submission authoring
Draft IND and NDA sections from approved evidence, tables, and prior filings, with the source behind every statement.
Health authority responses
Find the commitments and evidence behind an information request, assemble the response draft, and flag the points that need reviewer judgment.
Submission consistency
Compare claims, terminology, and data across CTD modules, the CSR, and prior filings so differences are visible before review.
Commitment tracking
Connect post-marketing commitments to owners, due dates, supporting work, and the correspondence that created them.
One platform designed to back your entire team. Take on the hardest work in biopharma with purpose-built agents.
Agents
Describe what you need: Enjamb plans, does the work, and delivers a cited, review-ready result.
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Connectors
Work inside Benchling, Veeva, Medidata, the LIMS, and the internal tools no catalog covers.
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Institutional memory
Turn decisions, methods, and history into linked pages the whole team can use.
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Channels
Assign work in Slack, Microsoft Teams, or Google Chat, and get the result back in the thread.
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Governance
Every action runs as a named person, inside their permissions, with a record you can audit.
Learn MoreCompliant with the most rigorous security and safety standards.
Explore securityEnjamb meets the highest industry standards for security and compliance. We include all the default controls enterprise teams expect: SAML SSO, SCIM provisioning, audit logs, IP allow-listing, data residency and lifecycle management, and more.
SOC 2 Type II
Independently audited controls for security, availability and confidentiality.
ISO 27001
Certified information security management across the platform.
HIPAA
Protected health information handled under HIPAA-compliant processes and controls.
Per-user attribution
The agent holds no credentials of its own. It acts as whoever asked, with their permissions, enforced below the model.
No model training
Your data is never used to train or fine-tune any model, by us or by any provider.
Certifications in progress.