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Building Regulatory Capacity: Best Practices for the Future


Companies generally focus more on the product and its manufacturing procedures but they tend to forget some crucial areas like marketing and labeling. The continuous changes in regulatory guidelines make it highly difficult for organizations to keep track of all the minute details. Above all labeling and packaging reworks are so costly and time-consuming that maintaining it along with the authority lawsuits pushes the organization into further losses. To survive in this difficult terrain, it is necessary to seek at least some solution. As such, there is no single solution that can cater to all the needs but there are few that if included in your strategy might reduce your regulatory risk levels.

A distinctive regulatory management system is based on three tenets: 

  1. A clear articulation of strategy and overall agency direction; 
  2. A well defined operating model based on efficient and effective processes and systems; and
  3. An organizational culture that harnesses the unique talents of employees and steers those talents toward achieving the agency’s mission.

Strong capabilities in all three components are critical and must be consistent and reinforce each other.

Regulatory Best Practices:

In the end, what needs to be considered is that establishing regulatory practice involves a series of processes. You need to think scientifically but at the same time, that scientific knowledge needs to get communicated in the same manner. Secondly, consistency counts as it proves your efficiency to the authorities in being compliant. Finally, collaborate with all the different teams to have a prior prediction. This helps in the long run in maintaining transparency in what you do. 

Now if this seems confusing or too much work then VISTAAR can help you by using its AI-enabled tools to leverage your workload. It even ensures additional cost and time saving by eliminating the need for outsourcing through its data security and control service.