Client Spotlight: The FDA Group, LLC

The FDA Group helps life science organizations rapidly access the industry’s best consultants, contractors, and candidates. Their resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. We are excited to shine our Client Spotlight on them! Check out our Q&A with their President & CEO, Nicholas (Nic) Capman!

Thank you for taking the time to speak with us! Let’s first start off with what does The FDA Group do?

In the same way that a person would use an accountant to help them with the IRS, we help drug and device companies with the FDA.

How would you describe The FDA Group as a whole?

The FDA Group is in business to enhance the quality of people’s lives whether it’s our clients, employees, contractors, vendors, communities, or the patients who receive the products. Our purpose lies in discovering meaningful ways to apply our experience, expertise, and passion for quality and everything we do.

How do we do it? We’re able to do this through our proprietary talent, selection process, and a deep-rooted culture built upon five core values. These core values are the heartbeat of our organization and focus on the following concepts:

  1. Respond with urgency – If you receive an inquiry and do not have an answer immediately available, let the person know that you have received their inquiry and we’ll get back to them within a certain amount of time, make query resolution swift and thorough.
  2. Find a way to make it happen – What are our best options to solve the problem? What have we learned from the past that can keep us from repeating a mistake? How will we integrate that learning into new behaviors or practices? I believe there’s a million to one reasons we couldn’t get done what we said we were going to do, but if you are being creative and innovative, you should be able to in a moral and ethical manner, find a way to make it happen.
  3. Communicate with radical candor – Set the right tone, offer direct criticism and genuine praise. Earn the respect of your team, not by demanding it, but rather by being worthy of it, be kind and respectful when delivering and receiving criticism and always be open to change.
  4. Be humbly confident – Do not be arrogant and be willing to put yourself in a vulnerable position in order to address the topic at hand. Know that no one is perfect.
  5. Be easy to work with – Whether you are dealing with clients, employees, consultants, or vendors, everyone deserves the same amount of respect and attention. Treat the janitor with the same level of respect as the CEO.

Those are great values! When did you start the company and how has it evolved since you started it?

I went to school to be a high school history teacher. When I graduated, the state of Massachusetts was going through budget cuts, so they were laying teachers off, not hiring teachers. So my first job out of college was selling phone service door-to-door. The talk in the office was get 2 years of sales experience under your belt and then you can go and sell pills to doctors. And that’s where the money is.

As a naive college student, I said, “Sounds good!” I waited two years, started applying for drug companies, but instead of getting hired by a drug company, I got hired by a multinational pharmaceutical engineering firm. At the age of 23, I was the head of North American business development, which some people say, “Wow! that’s very impressive” to which I reply, “You should be less impressed by me and more repulsed by the person that thought it was a good idea to make a 23-year-old head of north American business development.” (laughs) So needless to say, I did what most 23-year-olds would do and I made a lot of mistakes and learned a lot of lessons.

While I was there, I decided to get my MBA and I had a professor that said he started his first company at the age of 26, which was a bagel shop. And I said, “Well, I’m 26 so I have to start a company.” I started The FDA Group. My goal was to make an extra $15,000 a year and I used to run it out of my car in the parking lot during my lunch breaks.

And actually, here’s another anecdote. When I was searching for [history teacher] jobs, the only one I could find was in rural South Carolina. So I told my grandmother, I said, “Hey, Grammy, I think I may have found a job in South Carolina.”

And she said, “Oh, you can’t go there.”

 I said, “I can’t?”

She goes, “Oh, no, no, no, you have to stay here.”

I said, “Really?”

She goes, “Oh yeah.”

That 7-second conversation completely changed the trajectory of my life.

That’s an amazing story! Can you tell us at what point in the development of the company, did you realize this is something that’s bigger than I thought and this is going to be my full time gig?

Well, two things happened at the same time. One is that I started making more money at The FDA Group than I did in my job. The other part was Tim Lamm, my previous business partner who worked for me for six years, he convinced me, he said, “You need to stop doing everything else and just do this.” And then, I was a one man show.

And with my full-time job and The FDA group, I was working until midnight every night and most importantly I wasn’t there for my wife. She said, this isn’t going to work, you can’t do this every night so that’s when I was like, all right, well, if I can’t work till midnight every night, then I’m going to have to pick, so I quit my job just did this. And I hired Tim.

Wow! When you made that decision, how were you feeling about it?

Nervous excitement. Like going to a middle school dance.

In regards to your business, what are you most proud of?

I work for the comments, so different employees will tell me how amazing it is to work at The FDA Group. And I remember I was talking to Jason and he said, “I don’t think you realize what you’ve created here. I don’t think you understand that this doesn’t exist anywhere else. People don’t operate like this. They don’t create companies like this.” And those are the comments that I live for.

I told you my why, and it was to enhance people’s quality of life. The way I was able to define that is when I was implementing EOS, the Implementer said, “Do you get a case of the Mondays?” And I said, “I don’t.” And he said, “Why? Why do you wake up Monday morning and not get a case of the Mondays?” And I said, “Well, because I know what I’m doing every day is improving people’s quality of life. Because they’re coming into a company where they are trusted and they’re cared for and they’re just the culture itself.” So when I hear about somebody just saying, “I really like working here,” I know what that feels like. I’ve been an employee, and when they really like it, I know what that means. Then I hear about Marty buying a second home. I hear about Allen doubling the size of his property. When people are making these big purchases, I know that I played a role in that.

The thing I’m most proud of is the daily sentiments of my employees. I think about them like I think about my children. I care for them and want to see them succeed. And when they’re happy, I’m happy and when they’re not happy, I’m not happy.

Is there anything on the horizon for your business in 2022 and beyond that you’re excited about?

We’re creating a subscription model and we’re calling it the Insider Newsletter. Why are we doing it? Number one, it’ll increase the value of the company from 8-11x EBITDA to 15x EBITDA which strengthens our growth potential. Number two is it increases the visibility of The FDA Group so we have an increase in the number of job requests. Number three is it establishes The FDA Group as a trusted leader and number four is it increases revenue and net operating income.

How we’re going to do it is through a monthly sub-stack newsletter with embedded videos. Our marketing group is going to operate it with the help of full-time employees. We’re going to have three articles per month in the newsletter with at least one touching on pharma and one touching on device. We’ve established a team of over three dozen consultants that can be contributors to the newsletter. We’re having teams of 1-3 contributors to get different perspectives on each individual topic and then there’s one person that records the video with the information they got from the huddle.

How did you come up with the idea to do an Insider Newsletter? Because you have a company that is essentially a staffing model and that is what you’re doing now is a completely different type of business so you were adding in this revenue stream, that’s creative. And what led you to, what inspired you to think of that?

I read The Automatic Customer. I wanted to read The Automatic Customer because I knew I wanted to increase the value of the organization and one common way in order to do that is to have customers that are subscribers and you can rely on them every month, like Netflix, like a newspaper or whatever the case may be. I knew I wanted something like that, but I didn’t know what I could do. When I read The Automatic Customer, that’s when I started to kind of formulate this idea.

Moving now to the Accounting side of your business, before you started working with us, what problems were you experiencing with your Accounting?

It was a complete disaster. We hired you as a rescue. We used to work with the competitor of yours and one of the people that was on their team wanted to work for us full time. I spoke to them and they were okay with it. So I worked with this one woman and she did everything. Then she said she was moving, which that didn’t have any relevance because we’re all remote. Deep down, she just didn’t want to work for us anymore so we were able to convince her to let us hire somebody. She said “I’ll be here. As long as you need me.” That quickly turned into “I’m gone in two weeks.”

We had to rush and just hire anybody we could find and this is when we were doing a huge project. This was a big problem. We made the wrong decision to hire this guy that lived out of his mother’s basement. He was not qualified. He did not know what he was doing and he destroyed everything.

I met Matt (Garrett) at a Vistage meeting and timing was perfect. I was like, “I need your help.” And so you came in and you did the rescue. The idea was just for you to fix it and then we would hire another full-time employee to take over everything, but then when I saw your model, the redundancy is what got me excited. You have the Staff Accountant, the Accounting Manager, the Controller and the CFO. I knew when things turned, if somebody got hit by a bus, there were three other people there that could pick it up. And we’ve experienced turnover with you and 90% of the time, there’s no real issues.

Why did you decide to work with us and how have things improved or what solutions have we provided?

I brag to people that we have the best books that anybody’s seen and anybody that’s looked at our books would agree. We have the best books. No organization’s perfect, but our working relationship with TGG has been almost flawless and it’s definitely a partnership. I don’t feel like you’re a vendor. So professionally it’s running like a well-oiled machine.

I also like the fact that your books that you create, allow me to make real projections and decisions. Before I would have books and I’d look at it and say, “Okay,” and that was it, but now I get information so I can actually make decisions and projections. It was so illuminating when I made that transition from looking at numbers and saying, “Okay,” to getting the numbers and, and being able to point out things and say, “Oh, if we do this or that, and this and this other thing, this is what we can expect.” It drives decision making.

As we wrap up, what advice do you have for new entrepreneurs? What lessons have you learned throughout your career?

My gut reaction is get your MBA (laughs) and implement EOS.

We love to hear that we’ve made a positive impact in your business and everything you have to look forward to in the future. Thank you for the time, Nic!

To learn more about The FDA Group, check out their website:

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Nicholas (Nic) Capman

President & CEO of The FDA Group

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