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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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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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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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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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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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.
KNOW MOREFDAbasics LLC is an experienced provider of FDA regulatory consulting services, with an established base of global otc drug listing built over the last twenty years.
Our expertise spans the breadth of compliance services required to market FDA regulated products, including food, dietary supplement labeling, drugs, medical devices, and cosmetic labeling. We are a recognized US agent for FDA regulated industries or US agent for drug companies. We offer complete assistance to meet FDA regulatory requirements.
Our services for drug companies include U.S Agent service, Assistance for ANDA submission process , IND, NDA, NADA and drug registration, listing services self-identification, & complete assistance to meet FDA requirement. For food and dietary supplement companies, we offer U.S Agent, FSVP agent, Registration, Labeling review, FSVP assistance, fda SID number, ndc number, food facility registration services and other FDA compliance services. For medical devices, we offer U.S Agent services, fda registration and listing, as well as UID submission, medical device registration services 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.
