Built for Regulatory Writers. Finally.

Dossia is a purpose-built tool for regulatory submissions

Meet the AI-native workspace that tackles version chaos, table formatting, cross-team misalignment, and last-minute data updates — without ever compromising compliance.

See It In Action

When upstream data changes, Dossia automatically flags all downstream sections for review across multiple dossiers. No more hunting through documents or missing critical updates.

Upstream Change Detected

Study TX-017 – Repeat-Dose Toxicity FindingsUpdated
Previously
"No liver toxicity up to 30 mg/kg"
Updated
"Mild hepatocellular hypertrophy at 30 mg/kg (females)"
Cross-dossier dependency tracking active

Downstream Impact (Auto-Flagged)

Module 4.2.3.2 – Nonclinical Summary
Review Required

States "no liver effects at highest dose"

Module 2.6.6 – Summary of Toxicology
Shared Component

tox-summary-v2.1

Reused in 4 dossiers across 2 programs
Risk-Benefit Assessment
Narrative Conflict

Asserts "clean tox profile up to 30 mg/kg"

SME Note by Dr. H. Lin
Validation Needed

"Safety margin supported by clean tox"

Last reviewed 10 months ago

AI Suggestion
Revise safety margin rationale. Consider noting sex-specific liver findings. Flag SME note for update.

More Submissions. Fewer Hands. No Room for Busywork.

With a greater than 10% annual increase in regulatory submissions and leaner teams than ever, writers are under pressure to deliver more, faster — without making mistakes.

Dossia clears the runway so your team can stay focused on what matters: strategy, accuracy, and getting treatments to patients faster.

Built Around How Writers Actually Work

Stop rewriting the same sections

Reuse with traceability

Stop formatting by hand

Titles, tables, and text are auto-formatted to your style, even when data changes

Stop chasing last-minute changes

Trace and flag downstream updates, no guesswork

Stop wasting hours in sync meetings

Align teams without the calendar drain

Stop manually extracting data

Auto-extract tables, charts, and paragraphs from source documents

Stop worrying about audit trails

Every action is logged, versioned, and reviewable

Grounded AI, Not a GPT Wrapper

AI You Can Trust — Because It Doesn't Pretend to Know

We don't generate full drafts. We offer traceable suggestions grounded in source documents and regulatory guidance — always under your control.

AI doesn't push; it supports.

You're the writer. We just help you move faster.

Write With Confidence

Import regulatory components, track sources, and get real-time notifications when referenced data changes. Every element is traceable and compliant.

Upstream Changes Detected📊 Lisinopril DS Char

The referenced source has been updated. Review changes and update your document if needed.

Sources
1 📋 CFR 314.502 📋 CFR 211.843 📋 ICH M404 📄 SOP-0015 📋 FDA Q1A(R2)6 📄 NDA 1234567 📄 Lisinopril DS Char

3.2.P.2.1.1 Drug Substance Compatibility and Key Physicochemical Characteristics

Compatibility Assessment

The compatibility of the active pharmaceutical ingredient (API) with the excipients listed in section 3.2.P.1 has been systematically evaluated through comprehensive compatibility studies [4]. Binary mixtures of the drug substance with individual excipients were prepared and subjected to accelerated stability conditions as per ICH guidelines [3].

Excipient Compatibility Studies

Binary mixtures of the drug substance with individual excipients were prepared and subjected to accelerated stability conditions (40°C/75% RH) for up to 3 months [5]. The following analytical methods were employed:

  • High-Performance Liquid Chromatography (HPLC) for assay and impurity profiling [4]
  • Differential Scanning Calorimetry (DSC) for thermal behavior assessment
  • X-Ray Powder Diffraction (XRPD) for solid-state form evaluation

Writers Are More Than Writers

You drive the strategy, shape the narrative, and navigate ambiguity.

Don't let formatting, version control, and copy-pasting drag that down.

We built Dossia for those who:

Turn messy data into structured storylines
Collaborate with statisticians, clinicians, and chemists
Thrive in complexity — but are buried under logistics

Dossia lets you focus on your brilliance, not bureaucracy.

Compliance from Day One

21 CFR Part 11 ready
Encrypted at rest (AES-256) and in transit (TLS 1.3)
Zero data visibility — we can't see your data
SOC 2 Compliance (coming soon)

Get early access to the future of regulatory writing.

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✓ Early access to regulatory workspace

✓ Direct feedback channel with our team