Regulatory 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 US, it is the function of the Food and Drug Administration to establish these regulatory requirements and in India Department of Health.

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.

  • India - Schedule M
  • The Drugs and Cosmetics Act 1940. As amended up to the 30th June, 2005 regulate the import, manufacture, distribution and sale of drugs. Under Schedule M of the D & C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.

  • U.S.A – 21 CFR Parts 211
  • U.S. Health and Human services department, Food and Drug administration under -Title 21 part 211 regulations contain the minimum current good manufacturing practice for preparation of drug products for administration to humans or animals.

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.

Kindly contact us for more information.

INDIA – Bangalore
+ 91 994 591 2081
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USA – Chicago
+1 630 696 1293
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