Meet the AI-native workspace that tackles version chaos, table formatting, cross-team misalignment, and last-minute data updates — without ever compromising compliance.
When upstream data changes, Dossia automatically flags all downstream sections for review across multiple dossiers. No more hunting through documents or missing critical updates.
States "no liver effects at highest dose"
tox-summary-v2.1
Asserts "clean tox profile up to 30 mg/kg"
"Safety margin supported by clean tox"
Last reviewed 10 months ago
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.
Reuse with traceability
Titles, tables, and text are auto-formatted to your style, even when data changes
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We don't generate full drafts. We offer traceable suggestions grounded in source documents and regulatory guidance — always under your control.
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Import regulatory components, track sources, and get real-time notifications when referenced data changes. Every element is traceable and compliant.
The referenced source has been updated. Review changes and update your document if needed.
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].
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:
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