CEO One on One with The FDA Group President, Nick Capman

Earlier this May, the Worcester Telegram & Gazette sat down with The FDA Group's President and CEO, Nick Capman, to discuss the company's history and role in helping pharmaceutical, medical device and biotechnology companies with a variety of GxP auditing, remediation and regulatory requirements.

The discussion also explored how The FDA Group seeks to stand out from the competition as well as the challenges and rewards that come with business ownership.

Read a snippet of the conversation below, or click here to read the full CEO One on One interview on telegram.com.

From telegram.com:

In 2011, Nick Capman launched The FDA Group, an online consulting firm that advises and audits pharmaceutical and biotech companies seeking to have medication approved by the U.S. Food & Drug Administration. The FDA Group has five employees, soon to be six. Mr. Capman, who originally studied to be a high school history teacher, was hired as head of business development at a pharmaceutical engineering company after college. While earning his master's degree in business administration, he was inspired to begin his own business by a professors who had opened his own bagel shop at age 26 — the same age Mr. Capman was at the time. Originally a side project with a goal of making $15,000 a year, The FDA Group is now full-time business that expects to make $10 million in revenue this year. It is ranked 294th on Inc. 500's fastest-growing companies in the U.S., and No. 7 in Mass.

Where does the name The FDA Group originate?

“It originates from me. I wanted to pick a name where people would know what we do immediately. We help companies with the FDA. Just like you use an accounting firm to help you with the IRS, pharmaceutical and medical device companies use us to help them with the FDA. I wanted a name where people know what we do.”

What services does The FDA Group provide?

“...There are two service buckets. There’s the GxP auditing and remediation bucket, and there’s the regulatory bucket. Regulatory bucket is doing all of the paperwork with FDA: submitting applications so that you can test drugs on humans; submitting applications so you can get approval from the FDA; submitting packages so that they are prepared for your meeting face-to-face with them. The GxP auditing and remediation is the compliance. Simply stated, you can’t go manufacture pills in your bathroom. There are compliance requirements that companies have to follow to ensure that their products are safe. There’s two pieces: The first is auditing, so we’ll go in and audit a site or a company and identify where the problems are; and the remediation is the fixing of those problems.”

Click here to keep reading on telegram.com.

Photo credit: T&G Staff/Steve Lanava