Services to Ease FDA Regulatory Compliance

Monthly Archives: November 2017

US Agent for Medical Device Companies November 20, 2017

US Agent for Medical Device companies. All the foreign medical device companies  who are required to comply with FDA registration requirements should appoint U.S Agent for communication with FDA.  US Agent acts acts as medium of communication between FDA and foreign company. Pragmatic offer services to act US Agent for Medical Device companies. Responsibilities of … Continue reading US Agent for Medical Device Companies

FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING- NDC Drug Listing Renewal November 10, 2017

No Change Certification for drug listing (NDC Drug Listing Renewal )  is mandatory requirement in order to keep your current drug listing  active, if you have not updated your existing drug listing in the current calendar year. Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is … Continue reading FDA NO CHANGES CERTIFICATION OF PRODUCT LISTING- NDC Drug Listing Renewal

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