Advanced Consulting Services for the Pharmaceutical Industry

read about

01

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.

02

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.

US FDA Agent Services for Foreign Companies

About us

FDA EXPRESS LTD, a UESE International group company, began in 2021. The initial focus is on the services of US FDA agents to numerous foreign companies for the sale of medical devices, drugs and food products in the United States. Thanks to our experience we offer all of our services, namely DMF declarations, ANDA / NDA declarations and institution registration, as well as a number of other services related to FDA compliance. We are now proud to offer expert support that relies on over twenty years of business.

We are committed to providing the highest quality services for food, medical devices, medication and cosmetic companies. Our goal is to provide you with the advice you need, not just for regulatory advice but for your long-term business goals. We pride ourselves on offering expert, affordable solutions. We have worked with large and small companies, from around the world.

FDA EXPRESS LTD is headquartered in London and Florida USA

Services: FDA US AGENT

La nomina di un agente statunitense √® un requisito obbligatorio per le societ√† straniere che desiderano vendere farmaci o prodotti farmaceutici, dispositivi medici, alimenti e integratori alimentari, negli Stati Uniti. Possiamo agire come tuo agente e fornire servizi per supportarti con le normative FDA.

FDA EXPRESS leaves its customers with practices that allow you to develop and produce high-quality products with efficient, GMP-compliant operations that benefit long after the project may be over

We have earned a well-deserved reputation of trust, expertise, and highly successful project outcomes. We believe that expertise from our many years of experience and hard work equals positive results

FDA US AGENT

The appointment of an agent is a mandatory requirement for any foreign company wishing to market their products within the United States. FDAbasics can act as your FDA agent, as well as offering a suite of regulatory compliance services to help you through the FDA registration process and other FDA compliance services..

DRUGS

With a track record in supporting companies through the drug approval process, we offer consulting services for FDA drugs and pharmaceuticals compliance. This includes assistance for IND, NDA, ANDA, NADA,  ANADA   Establishment registration, OTC drug product listing, NDC number, SPL authoring , self-identification GMP compliance, as well as other regulatory compliance related to drugs.. 

MEDICAL DEVICE

We offer regulatory compliance services to Class I and Class II medical devices. Our services include assistance with Establishment registration and device listing, GDUID, 510(k) (Premarket Notification), PMA (Premarket Approval), De Novo (Evaluation of Automatic Class III Designation), and HDE (Humanitarian Device Exemption)..

Food/Dietary Supplement

Our FDA consultancy can deliver support to enable you to market your food and dietary supplements. We can provide complete assistance for  understanding FDA requirements  for  your products, facility registration, Process Filing for Acidified and Low-Acid Canned Foods (SID), food and dietary supplement labelling review, and FSVP related services..

COSMETICS

We provide VCRP assistance, as well as design and labeling review services, to help you comply with the FDA's labeling requirements for cosmetics companies..

Other Services

FDA EXPRESS offers a range of other regulatory consulting services, including quality system compliance, vendor audits, and managing the quality agreement with your contract manufacturer. We can help with all FDA compliance related services..

Contact Us

Our registered office address and general management

FDA EXPRESS LTD
Company Number 13158516 United Kingdom | 20-22  Wenlock Road London N1 7GU

info@fdaexpress.uk

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