How to Organize the Quality Agreement for Drug Products Manufacturing

Posted on April 16, 2023April 16, 2023 by admin

A quality agreement is a crucial document that defines the responsibilities and expectations of the parties involved in the manufacturing of pharmaceutical products. The quality agreement helps in ensuring that the product is produced in compliance with the regulatory requirements and also meets the quality standards. One of the essential aspects of the quality agreement is Read more about How to Organize the Quality Agreement for Drug Products Manufacturing[…]

Sponser Meeting with FDA some facts

Posted on August 18, 2020August 18, 2020 by admin

There are many meetings which a sponser can have with FDA related to the product being developed and to be approved by FDA. But it can be categorized in to 3 base categories. Type A: Critical Path (Urgent) meetings – Clinical hold, Safety Issues, Site disqualification, etc (within 30 days) Type B: Procedural meetings – Read more about Sponser Meeting with FDA some facts[…]