2018-06-01T12:28:51
Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing by Central Drugs Standard Control Organization (CDSCO). The regulations under Drugs and Cosmetics Rules describe the information required for approval of an application to import or manufacture of new drug for marketing.
Substantial documentation and data are required in these types of submissions, resulting in large, complex applications. Till date, applicants have used many different approaches in organizing the information and the differences in organization of data in each application has made reviewing more difficult and can also lead to omission of critical data or analyses. Such omissions can result in unnecessary delays in approvals.
Very often, a client simply doesn’t have the time to complete the work. That’s where ACPL Consulting services help. Our Team will work with you to ensure that your requirements are met and that your completed work is delivered on time and, crucially, within budget. We have outlined the major areas of Regulatory operations and expertise under each of the service areas.
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