Pragmatic Compliance 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.
Pragmatic Compliance LLC is headquartered in Florida, USA.
Pragmatic 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.
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.
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.
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.
What is ANDA?
ANDA is the Abbreviated New Drug Application, the FDA's generic drug approval process.. .... Read More
Who should file ANDA?
Any companies interested in obtaining generic drug approval should file ANDA.. .... Read More
What is a generic drug?
A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.. .... Read More
What information should be included for ANDA?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.. .... Read More
What are the ANDA fees?
For FY2017, the ANDA fee is $70,480.. .... Read More
What is the time frame for approval for ANDA Applications?
If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.. .... Read More
Who should register?
As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.. .... Read More
What information is required for Establishment Registration?
The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.. .... Read More
