[ ACADEMIC-TO-COMMERCIAL TRANSLATION ]

Taking research toward a regulated product

Ten paths for the position most guidance skips: a discovery that might become a product, held by people with no quality organisation yet and nobody down the corridor to ask. The obligations start before the hiring does.

WHAT THIS IS NOT

Orientation for translating research toward a regulated product — not a determination of device status, regulatory pathway, submission type or clinical adequacy, and not a substitute for qualified regulatory advice. SPEQ is independent: linked institutions, incubators and agencies are third parties, and nothing here implies affiliation, endorsement or partnership with any of them.

IF YOU READ NOTHING ELSE

The expensive early mistakes are almost never wrong decisions. They are undocumented ones — a material with no recorded provenance, a cell bank with no history, a process change nobody wrote down. Decisions can be revisited. Provenance cannot be reconstructed, because the people and the paperwork move on.

How to use this library

Find where your programme actually is, not where you would like it to be. Each path opens with the signals that you are there, what to decide now, and — the part that matters most early — which records to start keeping, because provenance is the one thing that cannot be reconstructed later.

New to GxP? Start with Navigator →

10 guidance paths

Journey order

1From a research result to a product hypothesisThe data looks real. Is there a product here, and what does that change about how I work?Before it is a product

2Intended use, claims and what they commit you toWhat am I allowed to say this does — and what happens to me if I say more?Before it is a product

3The evidence map before your next experimentWhat do I actually need to have proved, and am I about to spend money on the wrong study?Building the evidence

4A quality system proportionate to where you actually areEveryone says I need a QMS. Do I need one now, and how much of one?Building the evidence

5Preparing questions and evidence for a regulator meetingI can request a meeting with the agency. What do I ask, and what will they expect me to already know?Building the evidence

6Keeping the process intact from bench to manufactureIt works in our lab. Why would it not work when someone else makes it?Making it at scale

7Suppliers, facility and the readiness nobody audits until lateHow do I know my suppliers and my facility will survive an inspection I have not had yet?Making it at scale

8Staying submission-ready instead of assembling at the endEveryone describes the submission as a huge push at the end. Is there a way to avoid that?Toward submission

9Regulatory diligence for fundraising, licensing and partnershipWhat will a partner or investor actually look at, and what will make them reprice the deal?Toward submission

10Launch, and the obligations that begin at approvalWe are approved. What now — and what am I suddenly responsible for that I was not before?After approval

COMPLETE INDEX — ALL 10 GUIDANCE PATH

Every path names its official third-party sources and links them directly. SPEQ is independent of the institutions and agencies it links.

BUILDING AN AI-ENABLED CLINICAL WORKFLOW?

Twelve stages from context of use to controlled model change, with a worked synthetic imaging case and the six ways it goes wrong. Six questions to start.

AI-enabled imaging journey →

BUILDING IN ST. LOUIS?

The same paths, plus what the local bioscience ecosystem provides and where it hands off — with every organization link verified and dated.

St. Louis life-sciences startups →