FDA Drugs and Cosmetics Requirements

Regulatory requirements describe what is necessary for a new drug to be approved for use in patients, further; it requires environment, process controls, documentation and quality system requirement for the manufacturing of drugs and cosmetics

In the United States of America, it is the function of the Food and Drug Administration to establish and monitor these regulatory requirements.

The complexities in the laws and had their own methods for obtaining regulatory approval makes the task of getting and complying with the requirements made very difficult. The rising cost of meeting various country requirements led to the establishment of an International Conference on Harmonization (ICH). The ICH came up with common requirements accepted by all.

  • DRUGS: US FDA Drug Establishment Registration and Listing
  • To know more about USFDA OTC product registration and listing requirments read appropriate section from the left side menu.

  • COSMETICS: Voluntary Cosmetic Registration Program (VCRP)
  • To know more about USFDA Cosmetic registration and Ingrediant statement Filling read appropriate section from the left side menu.

We stay up to date with current regulations and Our experience prevent you making mistakes, or solve them if it is too late, so that you can be sure, you comply requirements in a single step.

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