FDA US Agent and Regulatory Compliance Services

Pragmatic Compliance is an experienced provider of FDA regulatory consulting services, with an established base of global clients built over the last twenty years.

Our expertise spans the breadth of compliance services required to market FDA regulated products, including food, dietary supplements, drugs, medical devices, and cosmetics. We are a recognized US agent for FDA regulated industries . We offer complete assistance to meet FDA regulatory requirements.

Our services for drug companies include U.S Agent service, Assistance for filing ANDA , IND, NDA, NADA and ANDA registration, listing services self-identification, and complete assistance  to  meet FDA requirements. For food and dietary supplement companies, we offer U.S Agent, Registration, Labeling review, FSVP assistance, SID, and other FDA compliance  services. For medical devices, we offer U.S Agent services, registration and listing, as well as UID submission and other services for device approval.

In the past 20 years, we have developed experience and understanding of the knowledge and skills needed to address a wide variety of regulatory issues. This means that we can offer solutions that add value, saving you both money and time. We believe in a transparent approach to business, and always put our customers at the centre of our work. We strive to achieve excellent customer satisfaction through superior services.

We offer the lowest guaranteed fees for a quality services. Our charges are disclosed upfront, and there are no hidden costs or increased annual fees.

 

services

  • 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. Pragmatic 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.

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  • 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.

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  • 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).

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  • 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.

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  • 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.

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  • Other Services

    Pragmatic 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.

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Why Pragmatic

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  • Over twenty years of experience.
  • Integrated regulatory solutions with core technical assistance.
  • Consulting services that consider your business and compliance requirements.
  • Payment after verification of our services: no advance payments are required.
  • Cost-effective pricing and high-quality services.
  • Free guidance on basic regulatory compliance.
  • Full customer confidentiality.
  • Fast and reliable service.
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Testimonials

Perfect Service for FDA registration

Perfect Service for FDA GDUFA self identification and Establishment Registration for foreign Companies. Prompt and round the clock Response
Nadine from Switzerland – Review on Trustpilot

quick response, flexible attitude, reasonable price

Ayako Fukushima from Japan on Trustpilot.com

 I was trying to work with a different company to have labels reviewed and not only were they expensive but rarely returned my messages.  I was so glad to find Rush at Pragmatic.  The prices were reasonable Rush quickly returned everyone of my messages with complete and thorough information.  Truly they were among the best organizations I have dealt with in starting up a new business.

Carol from Canada – Review from Yelp.com

I was very happy with Pragmatic’s service and would definitely recommend them! I had reached out to few other companies to get a quote on fees and turnaround time to assist our company and Pragmatic went over and above for us so it was a no brainer for us who we decided to move forward with. Very satisfied.

Thank you!
Anita from Canada on TrustPilot
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