Services to Ease FDA Regulatory Compliance

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.. .... Read More

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.. .... Read More

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).. .... Read More

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.. .... Read More

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.. .... Read More

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.. .... Read More

Translate »