Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a new global regulatory affairs (RA) division. RI provides up-to-date information of current regulations affecting the development, approval, and maintenance, as well as any changes to the regulations and/or regulatory landscape that impact the products. It is vital that important regulatory intelligence be effectively collected and communicated to the intended audience through appropriate channels. RI contributes to every biopharmaceutical company’s bottom line by helping the RA teams provide the highest quality submissions to agencies. 

Reasons for unsuccessful regulatory submissions include:

• Challenging to keep informed about the continuously changing rules and regulations by regulatory authorities.
• Loss of revenue because of not being compliant with any of the regulations.
• Knowledge gap between submission rules and local regulatory policies according to local requirements.
• Demand of time and resource for extensive research and analysis

How Regulatory Intelligence helps to overcome unsuccessful submissions:

• Regulatory intelligence is updated along with corporate intelligence
• Regulatory Intelligence keeps makes people understand the market impact whenever there is any change in the regulations.
• Identifies the “hot” topics that are widely quoted by regulatory authorities and helps to overcome them
• Keeps up-to-date on regulatory market trends
• Results in great reduction of approval time
• Results in cost effectiveness through risk analysis
• Increases target markets

Overall Influence of Regulatory Intelligence:

Having talked about all the important points of regulatory intelligence, it can be understood that a good regulatory strategy results from specific and well analyzed information of regulatory norms. Thus, Regulatory Intelligence will have an impact on the regulatory operations and also in designing a wide spectrum of a business portfolio for organizations. Regulatory Intelligence helps in effectively navigating the constant shifts in the Regulatory landscape and decreases the approval timelines thereby allowing more and more new drugs to reach the market.