Regulated writing, defined.

Periodic safety document submitted to regulators — covers PSUR, PBRER, DSUR, and ACO formats. Synthesizes safety data accrued during a defined reporting interval.

A cross-reference (e.g. “see Table 14.3.1.2”) that is bound to a stable structural identifier at the moment the section is drafted, rather than added as plain text and resolved later in a publishing pass. In Asthra, every “see Table X” or “as discussed in §Y” is pinned to a deterministic anchor derived from the caption text and section number; the Word add-in writes real bookmarks and resolved hyperlinks into the .docx. When sections reorder, numbers re-derive automatically and links stay correct. eCTD B21-ready by construction. See /product and the hyperlinks blog.

An explicit decision point in the agent's workflow where the writer must approve before the agent proceeds — typically when the agent needs an external lookup, encounters an ambiguous source-document classification, or wants to take an irreversible action. Distinct from a chat exchange: approval gates float on the section spine, have tier-coded styling (info, warn, high-stakes), and every decision is recorded in the audit trail. See Trust center.

An append-only record of every drafting action — retrieval, generation, revision, source version, model version — that produced a document. In Asthra, the ledger embeds in the .docx and travels with the file. See Trust center.

Contract required under HIPAA when a vendor handles protected health information on a covered entity's behalf. Asthra signs BAAs for HIPAA-bound deployments.

QC mode where citations are hidden from a reviewer until they explicitly request the source. Used to test whether a passage holds up on its narrative merits before provenance is examined.

Document required under EU MDR demonstrating clinical safety and performance of a medical device. Built around a literature search, appraisal, and synthesis of clinical data. See Asthra for CER.

Asthra's single Word add-in surface where every step of regulatory drafting happens — source ingestion, plan review, drafting, refinement, citation review, persona invocation, QC review, and reviewer handoff — in one continuous conversation tied to one document. The section overview, approval gates, and audit trail are first-class UI; the chat thread surfaces context but does not bury the document structure. Distinct from a chatbot bolted onto Word: the studio replaces panel-hopping with a single coherent surface. See /product.

A typed, queryable structure linking every assertion in a draft to its supporting source passage(s). Asthra's graph is two-level — section and sentence — and exposed via the Word add-in and an export API.

Default architectural property: the drafting agent has no unattended path to external sources. Evidence comes from a customer-managed source set. Internet retrieval requires explicit writer approval per lookup and is recorded in the audit ledger. Foundational to Asthra's hallucination control.

The Module 3 portion of a regulatory submission covering drug substance, drug product, and manufacturing controls. See Asthra for CMC.

An ICH E3-structured document describing the design, conduct, and results of a clinical trial. Typically the longest document in a regulatory submission. See Asthra for CSR.

The harmonized format for regulatory submissions across ICH regions. Five modules; Module 3 covers CMC.

The Asthra component that performs interactive, auditable data analysis over line listings, sales / exposure data, and lab parameter shifts inside the chat. The writer makes a natural-language request (e.g. “Grade 3+ AE table by SOC and treatment”); the LLM proposes the analysis plan; deterministic Python executes it; the output is an aggregated table or a figure ready to insert into the draft. Every step is logged with the exact code that produced the output. Distinct from LLM-only tools that ask the model to do the arithmetic itself: the numbers come from Python, not the LLM. See /product.

Annual safety report for investigational drugs in development, governed by ICH E2F. One of the document types Asthra supports under aggregate safety reporting.

A structured quality pass that runs over every finished Asthra draft, checking six categories: cross-reference integrity, statistical-claim source binding, defined-term ordering, citation density per section type, gap detection, and hyperlink resolution. The result is a structured QC report with pass / flag / gap per check, located down to the section. The QC pass is deterministic and reproducible; it is not a copy edit or a prose-quality review. For prose review, the writer summons a reviewer persona over the section. See /product.

European regulation classifying AI systems by risk tier and imposing obligations on high-risk deployments. Asthra is deployed and documented as a high-risk AI system.

The electronic repository of essential clinical trial documents. Asthra ingests sources from common eTMF systems via API.

Inline marker generated when source data needed for a section is missing, contradictory, or out of scope. Recorded in the audit ledger so reviewers see exactly which areas need additional sourcing.

Umbrella term for regulated practices: GMP (manufacturing), GLP (laboratory), GCP (clinical), GVP (pharmacovigilance), GDP (distribution). Tools used in GxP-bound workflows must be validated.

Workflow pattern requiring human review at defined points. Necessary but not sufficient — Asthra augments HITL with gated approvals and recorded decisions in the ledger.

Body that publishes harmonized technical guidelines across major regulators. Asthra encodes ICH E3 (CSR), E2C/E2F (safety), and M4Q (CMC) as module-specific writing rules.

U.S. regulatory submission types: Investigational New Drug, New Drug Application, Biologics License Application. CSRs, CMC, and safety reports feed into all three.

Stage of CER drafting where retrieved literature is screened, scored against inclusion criteria, and synthesized. Asthra surfaces the appraisal map alongside the draft.

EU 2017/745, the regulatory framework for medical devices in the EU. Drives CER content and update frequency.

European guidance on clinical evaluation. Specifies the structure and rigor expected in a CER; encoded in Asthra as the CER module rule set.

An organization designated by an EU member state to assess medical-device conformity. Reviews CERs and technical documentation as part of CE-marking.

ICH E2C(R2) format for post-marketing periodic safety reporting. Replaced PSUR for many regions; the names are often used together.

The traceable lineage of a claim — which source, which version, which retrieval, which generation. Asthra treats provenance as a first-class data structure rather than a side-effect.

Aggregate safety report submitted to regulators on a defined cadence. See Asthra for PSUR / PBRER.

EU-required role responsible for the pharmacovigilance system of a marketing authorization holder. Approves aggregate safety reports.

Generic pattern of grounding LLM output in retrieved documents. Asthra's closed-system retrieval is a stricter, regulation-aware variant — see Compare.

A reviewer perspective that can be summoned over any section of an Asthra draft. Today: FDA Clinical Reviewer, CMC Reviewer, CER Device Reviewer, CSR Writer QC. Each persona returns structured findings — a rubric anchor (e.g. ICH E3 §11.4.1), the snippet that triggered the finding, severity, suggested action. Every invocation is logged. Personas are SME-authored as markdown skills with YAML frontmatter, so domain experts add new personas without engineering involvement. Personas do not replace human review; writers use them to pre-empt reviewer feedback before the draft leaves the team. See /product and the skill registry blog.

The audit-ready package that ships with every Asthra run. Four artifacts: (1) the .docx itself, hyperlinked and cited; (2) a per-section provenance projection mapping every claim to its sources and transactions; (3) the end-of-run QC report; (4) a run manifest with model version, code version, token usage, and reproducibility metadata. The bundle is portable and vendor-independent — a regulator or inspector can download the four files into a folder and answer every question about how the document was produced. See /product.

The vertical thread of section nodes that anchors the Asthra studio UI. Each node represents one section of the document being drafted (e.g. §9.1, §9.2) and shows its status — done, active, awaiting approval, low confidence, or queued. As the agent works, nodes change state in real time; the writer sees progress at a glance without scrolling through chat history. The spine is the protagonist of the studio UI, not a sidebar — section structure drives the surface, not the conversation. See /product.

An Asthra unit of capability authored in markdown with YAML frontmatter. Skills include reviewer personas, validation passes, surgical edits, and composite workflows. A skill manifest declares what it does, which document types it applies to, which regulatory standards it references, and the shape of finding it returns. Skills are SME-authorable — your domain experts add new skills without engineering PRs — and every invocation produces a structured audit record (skill ID, version, rubric anchor, verdict, findings). See the skill registry blog.

AICPA framework for service-organization controls covering security, availability, processing integrity, confidentiality, and privacy. Asthra is SOC 2 Type 1 ready, Type 2 in progress.

The bounded collection of customer-supplied documents that Asthra is allowed to retrieve from for a given project. Defines the universe of fact for that draft.

Transport-layer encryption standard used for all Asthra traffic in transit, including Word add-in to backend.

Asthra's provenance model: every section is cited at the document level by default, and every sentence carries a sentence-level citation surfaced on demand.

Documentation bundle (URS, IQ, OQ, PQ, traceability matrix) that supports installation qualification of Asthra in a GxP environment. Available on request for Part 11-bound deployments.

Deployment in which Asthra runs entirely inside the customer's cloud account (AWS / Azure / GCP). Source documents and drafting traffic stay in-tenant.

An Asthra execution mode where the writer initiates a run, steps away from the laptop, and returns in 1–2 hours to a first draft with bibliography, hyperlinks, and an end-of-run QC report ready. When the writer reopens the document, the studio loads the full agent history (every retrieval, every tool call, every gap flag, every QC finding) so the review picks up natively. Walk-away delivers the first draft; the studio is where the writer applies judgement to bring the draft to submission-ready. The draft is a starting point, not the finish line. See /product.