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For Establishment Registration, 510k Submission, DMF submissions etc.

We are consultants and technical experts for 510k submissions

FDA Approval

FDA Approval

US FDA Approval

US FDA Approval the word has so much value, and across the Globe, manufactures and their marketing partners claim their products are “FDA Approved” or they display words on the company’s website, or in commercial promotions like flex, magazines, and brochures.


It is NOT correct in 95% of cases. FDA never approves all the products sold in the USA.


FDA controls the distribution of drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation, and most of these are NOT approved or inspected by FDA before the start of marketing these products in the USA.

US FDA Approval of Drugs

US FDA Approval of drugs means it is determined to provide benefits that outweigh its known and potential risks for the intended population. The FDA drug approval process with CDER is challenging and time consuming.


Once completion of US FDA Approval of drugs, it can be sold in the US market after establishment registration and Listing.


The final approval will come for a drug molecule after Preclinical Testing, Investigational New Drug Application, Clinical Trials, NDA Application, Drug Labeling, Facility Inspection, and finally, approval.


Currently, we are NOT providing US FDA Approval of drugs service for generic drugs. We provide registration and listing for the below category of items,

  • OTC Drugs.
  • Testing Laboratories.
  • Active Pharmaceutical Ingredients.

US FDA Approval of Food & Food Supplements

US FDA Approval of Food or beverages or dietary supplements neither Food manufacturing facilities do not have to obtain any approval before marketing in the United States. FDA Approval is required for Food Color and food addictives.


Currently, we are NOT providing the above FDA Approval service for Food manufactures. We offer the following services for food / dietary supplement / Nutraceutical manufactures across the Globe.

US FDA Approval for Medical Device

US FDA Approve only non exempted medical devices. The majority of the Class I devices are exempt, and NO approval required.


Class II & Class III devices have to follow PMA or 510k approval before marketing the device in the USA.

US FDA Approval for Cosmetics

US FDA Approve not required for the distribution of Cosmetics in the USA. We provide the following service for the sale/export of Cosmetics to the USA.