Simple and Affordable Solutions.

As the market leader we offer a comprehensive solution for a complete FDA registration process; we provide representation in the United States for companies and keep our clients' registrations with the FDA current. Our services will allow you to continue to export to the USA and avoid significant delays by the authorities at the border. As a company with long-standing experience in global trade and supply chain, we developed a comprehensive solution tailored to companies who export to the USA to overcome the new requirements.  We focus on efficient solutions that are effective at low cost.  We use automated systems where warranted to reduce errors and to expedite the process. Our 20 plus years experience in global trade, U.S. government agencies, compliance issues and exports to the USA will support your exporting business.

 

Partner Network

Through our partner network, you will also have access to highly specialized FDA resources.

 

Medical Consulting, including 510(k) applications

We offer consulting on the regulatory, clinical, quality and statistical aspects of drug, biologic, diagnostic, and medical device development. The major focus of our services are related to product approval support. Services include the following: regulatory and clinical strategies and implementation for pre-market submissions, pre-clinical and clinical study design, protocols, monitoring, clinical auditing, data entry, database management, statistical analysis and evaluation, report writing and training. We can also assist companies in setting up Design Controls, ISO and GMP compliance programs.

 

FDA Legal Services

We offer regulatory and intellectual property counsel to food, dietary supplement, drug, biologic, medical device, and cosmetic companies in the research, development, approval and promotion of their products in the U.S. and international markets.


Specialists in FDA Regulations.
We work with senior people who have at least 10 years experience in their respective fields, including government, industry and education.
“Our staff has experience with Government Agencies, Big-4 Consulting Firms and Industry. We have the experience that will help you become successful.”
register-FDA President

The Best Service at the Lowest Cost.
Together with our partners and hundreds of clients, we have developed the most efficient process to support your business.
We are a FDA designated U.S. Agent who resides and maintains a business in the USA.
We have access 24/7 to a dedicated FDA account to register your facility, or to update the information.
We have been involved since the introduction of the Bioterrorism Act in 2002 and supported, registered and maintained many companies worldwide.