- We offer one stop consulting service for FDA compliance related for Drugs ( Pharmaceuticals), which includes assistance for IND, NDA, ANDA, Establishment registration, OTC drug product listing, NDC number, SPL for prescription product labeling, self-identification GMP compliance or any other regulatory compliance related to drugs. We have assisted many companies to successfully clear the drug approval process.
Drugs (finished drugs and drug ingredients, OTC and prescription (RX) drugs) must be listed with FDA, manufactured and packed by an FDA registered facility, property labeled, and are subject to an FDA approved new drug application (NDA) when required.
Medical device must be listed with FDA, manufactured, packed, exported by, and imported by an FDA registered establishment, have proper pre-market notifications (PMN) or 510(K)s on file with FDA, and are subject to FDA approved premarket approval (PMA) when required.
Electronic products that emit radiation (or that would emit radiation if not properly shielded) are subject to FDA’s electronic product reporting requirements, resulting in FDA issuance of an FDA Accession Number for the manufacturer and the product. This requirement applies to all such products, even if they are not medical device, if they emit ionizing or nonionizing radiation.