REGNA RA Office · regna.kr/office
What an RA manager keeps open all day — the office.
On the far left sit everyday office tools — channels, mail, documents, search, the AI assistant Joshua. The further right you go, the more RA-specific they get (regulatory news → document redaction → regulatory Q&A and corpus → technical file review). Two promises — designed so you never paste, and no answer without a source.
Five ones · five things you only have one of
What makes it feel like one system is not the menu.
One REGNA account takes you all the way into the office, and inside there is one rail, one search, one copilot, one notification stream.
One login
SSO with your REGNA account, all the way into the office. Office accounts are created by an admin and you join with an invite code (B2B).
One rail
Channels, DMs, documents, mail, search, RA Hub and settings on a single rail. The trading-side menus (products, partners, orders, costs) are dropped from the RA face.
One search
Unified search across 9 sources. What you look for and what Joshua looks for run through the same pipeline.
One copilot
Joshua is the one place you hand work to. When you need regulatory knowledge, RA Hub's regulatory Q&A reads it deeply.
One notification stream
Channels, mail and the assistant's suggestions all arrive in one notification line.
One system · the gradient
From grey to RA colour, in one system.
On the left, office tools anyone uses; the further right, the more RA-only. To the buyer it carries one name: REGNA.
Office tools · everyday work tools
The work tools that come with it.
"Connect it, don't move it." Connect your mailbox, open a channel per product or application, build documents from templates. The AI acts; a person approves.
Joshua — an AI assistant that works on top of your company's data
It works across channels, mail, documents and templates. It drafts replies, fills in forms, builds tables, and recognises the screen you are looking at so it can answer "fix this document." A document edit only lands after a suggestion card → a person accepts, and nothing it produces is sent or posted on its own (approval gate). It uses only the numbers the tools gave it, there is a 7-day undo, and private DMs are encrypted, so not even Joshua can read them.
Projects › channels › conversations, files, notes
One room per product or application. Materials, discussions and notes pile up in one place, all indexed for search.
1:1 and group chat, encrypted
A sent message can be taken back within 5 minutes, and private conversations are encrypted. An answer in code to "does the AI read our chats?"
Template → filled values → a real .docx
Build documents from templates. The Korean official-document numbering scheme (1. / 가. / 1) / (1) / ① …) is guaranteed in code.
Outlook and IMAP — connect, don't migrate
Connect your existing mailbox instead of moving it. The AI reads it, organises it and drafts replies, but a person sends.
Unified search across 9 sources
Channels, mail, documents and regulatory material from one search box. Your search and Joshua's search use the same pipeline.
Accounts, permissions, invite codes, undo, audit log
Permissions are enforced structurally and every change leaves an audit record — meeting the B2B purchasing bar for access control and auditability.
RA Hub · the 5 REGNA tools inside the office
REGNA for knowledge, Joshua for execution.
RA Hub is where the five REGNA tools sit inside the office. The regulatory librarian (REGNA) finds and cites the source text; the working assistant (Joshua) acts on your company's data.
Document redaction (masking)
Before anything goes to an outside AI or a business partner, it automatically detects personal data, company names and figures and redacts them — not by covering them with black boxes, but by re-rendering the page so the characters themselves are gone. It re-parses the PDF it produced and shows a measured 「0 characters remaining」, and the original never leaves your browser. The redacted file attaches straight to a regulatory query. No AI — a rule engine plus human review.
Regulatory Q&A answered with the source text attached
It answers from a corpus spanning Korea's Medical Devices Act, notices, GMP and product standards through FDA 21 CFR and QMSR, EU MDR/IVDR and MDCG, and MDSAP, and the system attaches [Source N] to every claim. Exception clauses that would reverse the conclusion are forced into the search results, every answer goes through a two-pass self-check, and when there is no basis it says 「no supporting source」. A question close to an expert-verified Q&A is answered for 0 credits.
Technical file review — as findings
A two-layer structure: evidence verification (upload test reports, redaction required) → technical file review. It automatically maps standard packages such as ISO 10993 / IEC 60601-1 / EMC / 62304 / 62366 / ISO 14971 / ISO 13485 and returns conforming, non-conforming, missing or not applicable clause by clause, each with its basis. It joins the golden set only when a person presses 「Verified」 — no automatic pass. Advanced plan only.
Regulatory knowledge verified by practitioners
Post an AI Q&A as an article and practitioners and experts verify it. Three stages — unverified → expert verified → adopted — and only verified articles are indexed by search engines. From the moment it is verified, the same question is reused for 0 credits: collective verification becomes a company asset and cuts the bill.
MFDS, FDA and EU changes, cut to practitioner size
Three sections: domestic trends / overseas trends / new and amended laws and notices. Every card carries a summary, the authority, the date and a link to the source PDF. It is curation-first, and downloading the regulatory-change analysis is Advanced only.
What's different · the five points
Every one of these already ships.
- Redaction that really erases — and proves it — the page is re-rendered and 「0 characters remaining」 is measured, not claimed. The original never leaves your browser. Free.
- No source, no answer — citations are attached by the system, every answer gets a two-pass self-check, and when nothing is found it says 「no supporting source」.
- Search that does not miss the exception clause — borderline sources that reverse the conclusion are forced into the results.
- Collective verification becomes an asset and cuts the bill — expert-verified Q&As are reused for 0 credits.
- The AI acts, a person approves — suggestions, acceptance, undo, encrypted DMs.
Product · screens
RA Hub document redaction, the real screen.
Getting in
One account, one office per company.
Sign in with your REGNA account
Free to sign up, no card required. Signing in takes you into the RA office. If you do not have an office account yet, sign up with an invite code on the office sign-in screen or ask your admin.
Company-wide Office — by arrangement
A base fee plus seats plus a credit pool. You can start right away with a tax invoice and bank transfer. Send your company name and headcount to admin@tailgatelab.com.
Easy Regna series · no sign-in
Outside the office too, and free.
Easy Mask — document redaction
The same engine as RA Hub redaction, without signing in. No server upload · unlimited.
Product standard finder
By item code or item name, find the Korean individual standard in the 「의료기기 기준규격」 notice and the international standards it references. When there is no Korean individual standard, it says so and explains that you demonstrate conformity with the common standard and international individual standards instead.
Biological safety test selector
Choose the contact site and the contact duration and you get the biological evaluations you must run. The tables in the annex to 「생물학적 안전에 관한 공통기준규격」 are reproduced exactly, so the determination is deterministic.
KGMP product group finder
By item code or item name, the GMP product group and class come straight back with the notice behind them (Annex 3). IVD items are matched by major category too.
Digital device: in scope, code, grade
It decides under the notice whether a medical device or IVD with digital technology applied is in scope, builds the Annex 3 product code, and sets the class from the Annex 4 class table. It also shows the 62 reference cases from the guidance together with the borderline items that are hard to call.
Minor change finder
Describe the change in a sentence and it finds the Annex 3 minor-change item number and whether it is a 30-day or an annual report, then checks against the Annex 4 flowchart whether it is in fact a variation. Different wording still matches, through semantic search (bge-m3).
KGMP audit statistics
Statistics aggregating three years of GMP audit supplementary requests by product group, plus a clause wiki that attaches the actual requests to the Annex 2 requirement text.
Regulatory news
New and amended MFDS laws and notices, plus domestic and overseas regulatory trends, each with a link to the source. Browse and search by topic, and read without signing in.
Open the office now
regna.kr/office — one REGNA account gets you in.
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