Pharma Giant Leveraged RegASK to Proactively Monitor Regulatory Changes

The usage of dietary supplements and herbal medicine products continues to rise in several countries. However, the context of their usage varies widely across countries. While some restrict supplement use to general health and well-being, others allow it for medicinal purposes.  

Pharmaceutical companies may not be fully aware of the regulations governing dietary supplements and herbal medicines, which differ significantly from those governing drugs. Moreover, with the ever-changing regulatory landscape, pharmaceutical companies need to stay current on all regulatory changes related to food supplements, herbal medicines, and even drugs. 

The client, a Fortune 500 pharmaceutical company, was looking for regulatory intelligence solutions to help them stay on top of ever-changing regulations in the consumer health industry.  

Additionally, the increased volume and pace of regulatory changes made the client realize the need to automate and modernize their approaches to regulatory change monitoring for higher efficiency and compliance.   

Read the case study to know how RegASK used its AI technology and local experts to help the pharma giant take their regulatory monitoring system to the next level.   

Objective  

The regulatory department of this pharmaceutical company was manually gathering regulatory updates, a process that could have been more efficient and less prone to errors. Moreover, due to a lack of time and language barriers, the team needed help monitoring regulations in functional foods and food supplements worldwide.

Their existing process could no longer keep up with today’s pace and volume of regulatory changes in the consumer health industry. They certainly needed a regulatory intelligence platform that would enable them to capture all regulatory updates and centralize them in one place in a timely, reliable, and efficient manner. They also needed support to fill their knowledge gap on food supplements and herbal medicine regulations.

Solution 

RegASK was tasked with building a regulatory change monitoring system for the client’s product categories and keywords in 24 countries across the Asia Pacific, Europe, and the Americas. In a short period, RegASK managed to:  

• Leverage our regulatory intelligence platform RegAlert to help the client get easy and fast access to curated alerts and data analytics. (Our platform RegAlert uses AI technology to capture all regulatory changes and related news.) 
• Design a monitoring alerts dashboard tailored to the client’s product categories, including food, food supplements, herbal medicines, OTC and RX drugs, covering a wide range of regulatory topics such as: 

• • Product composition and formulation  
  • Labelling, claims and advertising 
  • Safety 
  • Packaging 
  • Importation 
  • Registration/notification  

Results 

The client took advantage of the RegAlert regulatory intelligence platform and global network of local experts to always stay on top of regulatory changes worldwide, allowing them to uncover risks and business opportunities in the consumer health industry.