About Us

FDAbasics, originally founded in 1995 as Tobias Systems, started with a simple mission: help foreign companies navigate the FDA. What began as US Agent services for medical device, drug, and food companies has grown over 30 years into a full-service FDA compliance practice covering registration, drug master files, ANDA and NDA filings, MoCRA cosmetics compliance, FSVP, and much more.

Today FDAbasics is a woman-owned business headquartered in Brooklyn, New York — still guided by the same mission we started with, and still run by people who genuinely care about getting it right.

We know FDA compliance can feel overwhelming. The regulations are dense, the deadlines are real, and the consequences of getting it wrong show up at the border. Our job is to make that process straightforward. We explain what is required in plain English, tell you exactly what needs to happen and when, and take care of the parts you do not want to deal with so you can focus on running your business.

What sets us apart is not just experience. It is the way we work. We respond quickly, give honest answers even when the answer is not what you were hoping to hear, and treat every client with the same care regardless of company size or budget. We have helped companies in over 100 countries get registered, stay compliant, and grow their US market presence with confidence.

If you are looking for an FDA compliance partner that gets it done right, communicates clearly, and actually picks up the phone, we would be glad to work with you.