Building Regulatory Capacity: Best Practices for the Future

Pharmaceutical companies are using various methodologies to ensure regulatory compliance with the health authorities. Still, there remains a loophole that prevents them from crossing the barriers set by the authority. This is where it becomes necessary to build an absolute regulatory capacity that would help the company in remaining ahead in the race. Now the question might arise as to where to start from and what would an ideal process be like? It is really necessary to begin the process through the creation of a unique regulatory strategy.  This should be done keeping in mind the need for regulatory best practices. 

Need for Regulatory Best Practices

• To gain easy approval from the authorities
• Attaining legal authority over a particular product
• Equally necessary for the protection of consumers and patients.
• Significant penalties for non-compliant practices. 
• Document Traceability from Regulations to Requirements

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:

• Continuous research on New Product & New Market Industry Benchmarks and Trends 
• Know Your Industry’s Regulatory Environment
• Determine your end goals, create effective policies and procedures 
• Intermittent review on Regulatory Strategy and Risk Assessment
• Understand the cross-functional impact of the strategy
• Resource and data requirements
• Process deployment plans with effective communication
• Precise execution integrating with technology

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.