How To Find Out Whether Your Regulatory Consultant Sucks


We’re working with a regulatory consultant but are not sure how capable they are. How to we find out whether our consultant sucks? And how do we identify good consultants?

Short Answer

Ah, glad you ask. This is a great question! Solving this will save you a lot of time and money, because crappy consultants cost a lot of time and money.
In short, here’s what separates good consultants from bad ones. Here’s a handy table:

Good Consultant
Bad Consultant
Project duration
2-3 months
12+ months
50-70k€ (fixed)
100-150k€ (hourly)
Done everything recently
Worked in startup
Software developer
More questions than answers
Creates fear
Shows documentation of other clients

That’s it. Any questions? Let’s dig into those aspects, read on!

Long Answer

Ahh. Even after having (successfully) worked with 100+ companies, I still see companies choosing other consultants and losing lots of time and money. Many of them come back to us later. It’s very frustrating, because I always tell them “look, you’ll regret this decision, it doesn’t sound wise”, yet they do it. Sigh. I guess B2B consulting decisions often aren’t made rationally.

So let’s hope you’re different.

Project Duration

The first aspect of a good regulatory consultant is that they can give you an accurate time estimate of when you’ll be done with your certification. Just like a good plumber: They arrive at your house, tell you “okay, this will take 3 hours”, and get to work.

Most regulatory consultants would probably be crappy plumbers, because they are not capable of this. They usually say hand-wavy things like “ohhh setting up a QMS is so hard and everything has to be customized to your company, yadda yadda”. None of this is true.

Firstly, all startup companies are essentially the same. Other consultants trying to convince you otherwise are mainly attempting to exploit your nacissistic tendencies as a founder – no, your company is not a special snowflake.

Secondly, setting up a QMS is not hard. It’s a bit like filing your taxes: In the end, you have to fill out a bunch of forms. Sure, you can overcomplicate this and do all sorts of workshops on what VAT is or whatever, but in the end, the output is documentation, and estimating the time for that is as simple as dividing the sum of total documents by the amount of documents you can create per day.

One side aspect of this is that a good consultants can show you what the actual work looks like. When companies ask me this in sales calls, I simply say “it’s simple, check out our templates – most of the work is filling those out”. Bad consultants say hand-wavy things again like “ohh that’s very complex, it’s about quality management”.

In our experience, the actual works takes around 2-3 months, and we have lots of past customer references to prove it. Bad consultants usually take 12+ months, and they don’t provide estimates at all.


The plumber analogy works here, too: A good plumber can give you an accurate price estimate before getting to work. Often, those are fixed prices, which makes sense, because the plumber has done similar things many times before, and people love fixed prices because they hate being surprised by huge invoices.

Unfortunately, most regulatory consultants are pretty bad here: They don’t provide fixed-price offers at all (crazy). They prefer to charge by the hour, which incentivizes them in the totally wrong way! Because now they have to try to bill as many hours as possible, which means they’ll try to make things as complex as possible, because that enables them to bill many hours.

It now makes sense that most projects with other consultants take 12+ months and cost 100-150k€.

We charge 50-70k€ and make it a fixed-price offer. Additionally, you don’t pay upfront, you only pay when work actually gets done.


When doing your tax return, the financial authorities of your country already provide you with forms and you only need to enter the numbers. For medical device compliance, it’s unfortunately different: Everyone has to come up with their own “forms”. We call those templates.

Before OpenRegulatory entered the space, consultants would sell these templates at mostly-outrageous prices – charging 5-10k€ for a bunch of Word files was considered normal.

We started offering our templates for free because we thought that was shady. I hope you agree with us.

So choose a consultant who offers free templates. Or, if you really want to work with them and they force you to purchase their templates (even more shady!), request a free sample and compare it with our templates.

In my experience, our templates are more complete while also being shorter (!). This translates to huge leverage in getting things done fast: It’s easier to fill out 3 pages than 30.

Done Everything Recently

You want a consultant who has recently finished a very similar project. If you’re a software startup, you should choose someone who has recently worked with a software startup successfully. Don’t choose someone who e.g. has experience with surface disinfectant agents. That doesn’t make any sense.

Worked In a Startup

Startups are different than enterprise companies. For one, people in small startups actually get a lot of stuff done and don’t spend time in endless meetings.

Senior regulatory people (consultants included) from large companies are often rather useless in a startup context, because they’ve been hyper-specialized on a certain area, e.g. they were a “CAPA Manager”. Besides the obvious question what a CAPA Manager does all day long (I don’t know), the bigger issue is that that person would not be able to help you get everything done, because they were busy managing only CAPAs for the last few years.

If you tell that person to help you with your Software Development SOP, you’ll likely see a blank face staring back at you.

Software Developer

The best regulatory people are also software developers.

I do confess that this combination is extremely rare, because developing software is very fun, and most software developers are rather smart. Now, try to convince a smart person doing a fun activity which they love (developing software) to fill out boring documentation all day long (regulatory affairs) or become a consultant. Ugh. Only weird people with idealistic motivations (hey, that’s us) do that.

But, still.. these people exist, and they tend to be much better than other consultants.

The main, huge benefit is that you don’t lose multiple days (yes, days!) explaining software development basics to them. I remember how other consultants didn’t understand the concept of git and GitHub. Ugh!

More Questions Than Answers

This is what I see happens with crappy consultants. Let me explain: Many of our clients talked to other consultants in the past, and the recurring conclusion of those calls was “they made everything sound so complicated and we ended the call having more questions than answers”.

I also see this happen with bad tax advisors: You schedule a call, ask one question, and instead of answering it, they ask you 10 questions back and make everything seem terribly complex. I hate that. They could have just answered my one question instead.

When people talk to us, they often say “damn, this helped me so much”, and that’s the way it should be.

So ask yourself after having an initial call with a prospective consultant: Did they answer your questions? Do you know what to do now?

Creates Fear

Bad consultants try to scare their prospective customers into purchasing services.

Example #1: “Oh man, your software sounds like a class IIa device for sure! No way that this is only a lifestyle device! But the good news is that you can purchase our help for 150k€ and we’ll get it done for you!”

Example #2: “Do you even know what being a medical device manufacturer means? It’s risky and dangerous! But no worries, work with us and you’ll be okay.

The truth is that compliance is just a pile of work (like taxes), and there’s no need to manipulate people into becoming scared of it, just to make more money.

Shows documentation of other clients

This is the one weird thing which I’ve seen repeatedly done by crappy consultants: They show documentation of other clients. If you think that sounds crazy, well.. ask some founders who are working with bad consultants. It happens surprisingly often that they show you documentation of their other consulting clients.

We took a very different approach: Instead of showing stuff around, we instead put in more effort in the beginning in creating our own set of templates, and we share those for free on our website.


Choose wisely – choosing a good consultant is not hard if you know what to look for.

And.. if you were wondering like “hey, all of this sounds like the OpenRegulatory people”, that’s no coincidence, haha.. I’m not a huge fan of self-advertising, but we do have 100+ happy customers, we do get stuff done 3-4x faster than other consulants (2-3 months), and we do it ~50% cheaper. Reach out if you’re interested!


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