Voice to Text for Regulatory Affairs Specialists
Regulatory affairs demands precision and speed in equal measure. Between FDA submissions, CMC documentation, and compliance correspondence, you're drafting thousands of words daily while navigating complex regulatory requirements and tight agency deadlines. Blurt lets you speak your first drafts naturally while your hands rest. Hold a button, dictate your submission rationale or compliance response, release. Text appears wherever your cursor is — in Word, regulatory portals, email, anywhere. Your regulatory expertise flows faster when your fingers aren't the bottleneck.
The Typing Problem
Drafting FDA submission documents under agency deadlines
The 510(k) submission deadline is next week and you still have 50 pages of predicate device comparisons to draft. Your fingers ache from typing substantial equivalence arguments, intended use statements, and device description sections. Every paragraph needs precise language that will satisfy FDA reviewers, but your typing speed can't keep up with your regulatory knowledge. You know exactly what the agency needs — your hands just can't deliver it fast enough.
Writing CMC documentation with exacting specifications
The Chemistry, Manufacturing, and Controls section requires meticulous detail about manufacturing processes, specifications, and analytical methods. You're typing batch formulas, stability data narratives, and method validation summaries. Every number, every unit, every procedural step must be accurate. The mental load of precision documentation combined with hours of keyboard work leaves you exhausted before Module 3 is complete.
Compliance correspondence that requires careful wording
The agency issued a Complete Response Letter and your reply needs surgical precision. Every word in your response will be scrutinized. You're crafting deficiency responses, commitment letters, and meeting request packages. You could articulate your regulatory strategy perfectly in a meeting, but translating that fluency to typed text takes three times as long. The gap between what you know and what you can type is costing you hours.
Regulatory intelligence notes from agency meetings and guidance reviews
You just finished a Type A meeting with FDA and need to document the agency's feedback while it's fresh. Or you're reviewing new guidance documents and capturing implications for your submission strategy. Pre-submission meeting minutes, guidance analysis memos, regulatory impact assessments — all require rapid documentation of complex discussions. Your thoughts fade while your fingers struggle to keep up.
Managing multiple submissions across different regulatory pathways
The NDA amendment is due Monday. The EU variation needs filing by Wednesday. The Health Canada correspondence can't wait past Friday. You're context-switching between regulatory frameworks, document types, and submission formats. Each pathway requires your full expertise, but your typing speed limits how much regulatory work you can actually deliver in a day. Deadlines stack up while your hands slow you down.
How It Works
Blurt works in every application regulatory affairs specialists use — Microsoft Word, Adobe Acrobat, regulatory submission portals, eCTD publishing systems, email. Anywhere you can place a cursor.
Hold your hotkey
Press your chosen keyboard shortcut. A small indicator confirms Blurt is listening and ready.
Dictate naturally
Speak your submission rationale, compliance response, or regulatory assessment. Blurt handles punctuation and regulatory terminology.
Release and continue
Text appears at your cursor instantly. No copying, no pasting, no app switching. Your document grows while your hands rest.
Real Scenarios
Drafting FDA submission documents
You're writing the substantial equivalence section for a 510(k) and need to articulate why your device is as safe and effective as the predicate. Hold the button and speak: 'The subject device is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance specifications. Both devices are intended for the same patient population and clinical indication. The differences in materials do not raise new questions of safety or effectiveness.' Three sentences dictated in 15 seconds. Your regulatory rationale flows directly onto the page without the friction of typing.
Writing CMC documentation sections
Module 3 needs detailed manufacturing process descriptions. Hold your hotkey and articulate the process: 'The drug substance is manufactured using a five-step synthetic process. Step one involves the condensation of starting material A with reagent B under controlled temperature conditions. Each intermediate is isolated and tested against established specifications before proceeding to the subsequent step.' Technical documentation delivered at the speed of speech. Your hands rest while your process knowledge does the work.
Responding to agency deficiency letters
FDA raised questions about your clinical data and you need to craft a precise response. Hold and speak: 'In response to the agency's request for additional safety data, we are providing updated adverse event tabulations covering the extended follow-up period. The incidence rates remain consistent with those reported in the original submission and do not alter the benefit-risk profile.' Compliance responses articulated with the precision of a meeting, delivered with the permanence of documentation.
Documenting agency meeting minutes
You just concluded a pre-submission meeting with FDA and need to capture the discussion while details are fresh. Hold the button and dictate: 'The agency confirmed that the proposed clinical trial design is acceptable. FDA recommended including a subset analysis for the pediatric population. The division indicated that a 505(b)(2) pathway remains appropriate given the referenced listed drug.' Meeting outcomes documented in real-time, not reconstructed hours later from scattered notes.
Preparing regulatory intelligence memos
New FDA guidance just dropped and your team needs an impact assessment. Hold and speak: 'The revised guidance introduces new recommendations for biocompatibility testing under ISO 10993-1. Key changes include updated requirements for chemical characterization and a risk-based approach to biological evaluation. These changes will require modifications to our current testing strategy for devices in prolonged contact with tissue.' Regulatory analysis captured while your insights are sharp.
Drafting regulatory strategy documents
Leadership needs a regulatory pathway assessment for the new product. Hold the button and explain: 'Based on the device classification and intended use, we recommend pursuing a De Novo pathway. The absence of a suitable predicate device precludes 510(k) clearance, while the low-to-moderate risk profile does not warrant PMA requirements. Estimated timeline to market authorization is 12 to 18 months.' Strategic recommendations delivered at the speed of conversation.
Creating compliance training materials
The quality team needs updated SOPs on regulatory submission procedures. Hold and speak: 'All regulatory submissions shall undergo internal review prior to agency filing. The regulatory affairs lead shall verify compliance with current formatting requirements and applicable guidance documents. Any deficiencies identified during review shall be documented and resolved prior to submission.' Procedural documentation completed faster when you can speak your process expertise directly.
Why regulatory affairs specialists choose Blurt over built-in dictation
| Blurt | macOS Dictation | |
|---|---|---|
| Regulatory terminology | Handles FDA terms, regulatory acronyms, and compliance language accurately | Frequently mangles regulatory terminology and agency names |
| Activation | Single hotkey, instant response | Menu navigation or voice command required |
| Speed | Text appears in under 500ms | Multi-second delay before transcription begins |
| Reliability | Consistent accuracy across long documentation sessions | Accuracy degrades, requires frequent restarts |
| Privacy | Audio processed securely, not stored | Uncertain data handling for confidential submissions |
Frequently Asked Questions
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