Research program · Regulatory correspondence

We want to understand how regulatory correspondence actually works.
Not how it's supposed to.

Adlib is building software for health authority correspondence. Before we build any more of it, we want to sit with the people who handle the queries, chase the evidence and track the commitments, and hear how that work runs today.

Before you ask

A research conversation, not a sales call

We’re a software company. You will have guessed that, and you’re probably already wondering when the demo starts.

It doesn’t. This is research, run by our marketing team, not by a salesperson. Nobody from our sales team is on the call. We’re not going to show you a product, send you a proposal, or add you to a mailing list afterward.

We’re asking because we’re designing something for regulatory correspondence, and we’d rather find out now that we’ve misunderstood the work than after we’ve built it.

What we’ll cover

Your process, in your words

We’ll walk through what actually happens, end to end. Roughly:

  • A question or information request arrives. Where does it land, and who sees it first?
  • How does it get classified, logged and routed to whoever owns the answer?
  • When you need to point at evidence in a filing that ran to hundreds or thousands of pages, how do you find it?
  • What happens to the commitments made in the response? Who tracks them, and in what?
  • Where does the process break, and what’s the workaround everybody uses?

That last one is usually the most useful answer of the hour.

We’re interested in the spreadsheet nobody admits to, the inbox rule, the shared mailbox, the folder on someone’s desktop. Those are the process.

Who this is for

Who we’re hoping to talk to

You’re a fit if you personally touch health authority correspondence, or you run the people who do. Titles vary a lot, but typically:

Manager or Lead, Regulatory Correspondence, Regulatory Operations or Regulatory Affairs

Regulatory Affairs Specialist, Analyst, Associate or Coordinator

Submission or publishing operations, regulatory information management, records

Anyone whose job involves the words “we have 30 days to respond”

Sponsor, CRO, biotech, device, combination product. All useful. You do not need to be a customer, and most of the people we’re talking to aren’t.

The thank you

$100, or $100 to a charity you name

For 45 minutes of your time, you can choose either:

A $100 Amazon gift card

Sent to whichever email you prefer.

A $100 donation

To a charity of your choosing, in your name or anonymously, with the receipt sent to you.

Plenty of companies have policies about accepting anything from a vendor, and we’d rather not put you in an awkward position. The donation option exists for exactly that reason. Pick whichever is simpler for you, and if neither works, tell us and we’ll do the interview anyway.

Ground rules

What happens to what you tell us

  1. We’ll ask to record the call, in writing, before it starts. If you’d rather we didn’t, we’ll take notes instead and it makes no difference to us.
  2. Please don’t share anything confidential. We don’t want your submissions, your correspondence, your data or anything under NDA. We want to understand the shape of the work, which you can describe without any of that.
  3. Findings are aggregated across everyone we speak to. Nothing is attributed to you or to your company, internally or externally, without asking you first and getting it in writing.
  4. Your details don’t go into a sales sequence. If we ever want to follow up about something other than this research, we’ll ask.

Book your 45 minutes

Four questions, then you'll pick a time that suits you.

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Before you book

Questions people ask

Is this really not a sales call?

Really. No salesperson is on it, there’s no demo, and nothing is sent to you afterward unless you ask. If we do a bad job of that, tell me and I’ll fix it.

How long is it, honestly?

45 minutes, and we finish on time. If you have less, say so when you book and we’ll cut the scope rather than run over.

Can I accept the gift card?

That’s your company’s call, not ours, and plenty of people can’t. The charity donation is there for that reason, and you’re welcome to take neither.

Will you use my name or my company’s name?

No, not without asking you first and getting it in writing. Findings are aggregated across everyone we talk to.

What if I’m not the right person?

Book anyway and tell us on the call, or point us at whoever is. Either helps.

Who else are you talking to?

People doing this work at sponsors, CROs, biotechs and device companies, at a range of sizes. We’re not naming them, the same way we won’t name you.