Blogs

Organizations often face unforeseen risks when they tread on the uncommon roads of the life science sector. They are often termed as in compliance or compliance issues, which has a direct impact on patient health and safety. Better insights regarding the existing and ever-changing market might be helpful in surviving such competitions. Regulatory consultants are the need of the hour as they make the path easier. They not only provide the regulations for submission in various geographical areas but also keep a check on the issues that might hamper the drug review process. Regulatory Intelligence caters to these areas within the industry.

Understanding Regulatory Intelligence:

Regulatory Intelligence is an integral part of regulatory affairs (RA) but it has a much wider scope in comparison to preparation and submission of applications to regulatory health authorities. Its primary function is to update the company regarding the variations in drugs, devices, diagnostics, food and cosmetic regulations so that they can stay on track. Regulatory Intelligence aims to help in future decision-making by concentrating on historic decisions made by regulatory agencies. It ensures that submissions made by the Regulatory Affairs team are quality maintained.

Why Regulatory Intelligence is Necessary for Biopharma?

• Ever-changing Regulations: Regulatory changes are continuous when it comes to the pharmaceutical industry. Staying updated is necessary as minute changes have a severe impact on the business.
• Data related decision-making: Regulatory Database allows in the accumulation of relevant data and organizations that use these data in their decision-making process are more productive. The impact is so significant hence, it is difficult to ignore. 
• Eliminating Errors: A well-managed Regulatory Intelligence Software ensures that there are lesser mistakes as manual processes are never free of issues. Accuracy achieved through automated services not only makes the work process faster but it even leads to maximum cost savings.  
• Increasing Workload: Manual management and tracking system requires more time in assessing competitor work process. On the other hand, a Regulatory Intelligence tool can do so within a short span of time levering the workload from manual workers and letting them concentrate more on research subjects. 
• Data Analysis & Interpretation: Regulatory consultants provide regulatory intelligence and their job is not limited to application and submission of application. They have an extended role of analysing and interpreting data and providing added insights that would be useful for companies in their journey ahead. Regulatory consultants do risk analysis through research of current market scenario.  

Regulatory Intelligence for Medical Devices:

Medical device manufacturers have to work within a tight schedule to get their products approves and even manage the product quality along with patient safety. This often leads to generation of warning letters from the regulatory authorities. This is where regulatory intelligence plays an important role by decreasing the workload and enabling you to get hassle-free approvals.

Regulatory Intelligence for Cosmetics:

Staying up-to-date is the norm in order to ensure compliance. Companies use regulatory intelligence in strategizing, as non-compliance tend to have severe consequences. Compliance in the cosmetics industry ranges from product authorization to ingredient categorization. Europe cosmetics industry follows Regulation 1223/2009, and in Canada, the Food and Drugs Act is followed.

Regulatory Intelligence for Food Supplements:

Registration process for food and food supplements do vary from region to region. Hence, manufacturers find it difficult to place their products in global market. Regulatory intelligence database brings all these requirements in one place, which can be utilized by manufacturers. Maintaining regulatory compliance when it comes to food is essential as human security is dependent on it. In Europe, Regulation (EU) 1333/2008 is for additives and ingredients and the regulation (EU) 1169/2011 is for labelling. While in the US it is managed by FDA and CFR. 

Regulatory Intelligence helps you in gliding through the uneven regulatory landscape. You have a much reduced time-to approvals, which allows you to make your innovative drugs available to the patients. Every process is interconnected and hence for organizations which access regulatory intelligence faster, other process tend to follow smoothly thereafter.