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Regulatory Affairs

There are groundbreaking changes happening in the pharma regulations. With decades of regulatory affairs experience, we at Pharmawisdom are in the best position to help you prepare a regulatory strategy and assist in various filings

We excel in:

Preparation of the regulatory strategy

Preparation of dossiers for

  • Marketing permission
  • Clinical trial application


Representing the organization at regulatory body meetings

Regulatory support to marketing

  • Package insert preparation
  • Label /carton artwork approval
  • Amendments in the above based on changing laws

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