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
• PSURs/PBRERs

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

Click here for some articles

• Is the Drug Regulatory Situation in India Unique?
• Drug control – what it means for the society?
• Expanding role of ECs – are we prepared?