regulatory affairs

What Are the Steps Involved in Regulatory Approval?

The regulatory approval process typically involves several steps:
Preclinical Testing: Initial testing on animals or in vitro systems to evaluate toxicity.
Clinical Trials: Testing in human subjects to assess efficacy and safety.
Submission of Data: Compiling and submitting data to regulatory bodies for review.
Review and Approval: Regulatory agencies review the data and issue approval or request further information.
This process ensures that any potential adverse effects are identified before a product reaches the market.

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