About Us

Who We Are

FDAbasics LLC, previously known as Tobias Systems, started in 1995. The initial focus was on FDA US Agent services to numerous foreign companies for selling medical devices, drugs, and food products in the United States. As our experience built, so did our services, to include DMF filings, ANDA/NDA filings, and Establishment Registration, as well as a range of other services related to FDA compliance. We are now proud to offer expert support that draws on over twenty years of operation.

We are committed to providing the highest quality services for food, medical device, drug, and cosmetics companies. Our focus is on providing you with the advice you need, not just for regulatory consulting but for your long-term business goals. We pride ourselves in offering expert, cost-effective solutions. We have worked with companies large and small, from all around the world.

FDAbasics is headquartered in Florida, USA.

Why you should choose us

Our Experience

FDAbasics has provided US agent and regulatory services for the last 20 years, supporting clients across the globe. We have expertise in handling regulatory matters and communication with the FDA, an essential element of successful consultancy services. Our experience means that we can apply what we have learned over the years to help you address any regulatory challenges.

Our Approach

We believe in ethical business and maintain strict client confidentiality. We believe in sharing our knowledge so that our customers can understand all requirements of the FDA. We do not offer any advice to just sell our services. Instead, our objective is to fulfil the business needs of our customers.

Our Pricing

Our fees are straight forward, with no hidden charges. We do not hike our prices each year of your subscription, and we aim to keep our fees as constant as we can. We have not raised our prices for the past three years, and guarantee a cost-effective solution.

Our Services

We are committed to providing fast turnaround times and a prompt response to all our customers. We know that regulatory related matters can have a direct impact on your business, so we work as quickly as possible to transfer information between our clients and the FDA.