Regulatory being such a vast field of operations, often tend to create confusion for what means what. One of the most dominant services of regulatory consulting that often arrives with misapprehensions is Regulatory Intelligence (RI). Regulatory Intelligence allows the regulatory professionals to determine the requirements for global clinical trials, compliance procedures, manufacturing requirements, advice personnel, answer strategic regulatory questions and develop a global marketing application. Going further with this blog will help you have more clarity about what is Regulatory Intelligence and how it works.
If you go by books there may be hundreds of words defining what RI stands for. However if you want to get the essence of RI just remember three points:
- Gather Data
- Analyze Information
- Regulatory Strategy
In plain simple words, RI collectively comprises of three main segments which are followed while performing RI activities. To start with, let’s understand how each process works.
- Gathering Data
There were times when regulatory specialist used to restrict RI activity to this aspect only. However when there were gaps found in the input and output, it was obvious that some important facets were missing from the shelf. That’s when the other pieces came into picture.
To start with, RI professionals perform profound research about regulatory norms as per a particular product in a particular geography. As far as collecting relevant regulatory information is concerned, there are lot of sources that RI professionals leverage to consolidate their research material. Some of these resources can be:
- Regulatory Information on Websites, Blogs and Social Groups
- Professional Newsletters
- Competitor Product Analysis
- Seminars and Training Sessions
- FOI Requests
- Regulatory E-mails
- Professional Networking
- Guidance Documents
- Warning Letters
- Analyzing and Processing
Since the initial phase comprises of extensive research material, it becomes evident that this data needs to be filtered out to obtain relevant information as per the purpose. You can think of it as pieces of a puzzle and now we have to make sure that all pieces fall into place to get what is necessary. An effective Regulatory Strategy communicates the right solution and encourages for proper planning within various disciplines of an organization, right from manufacturing to marketing
This activity includes taking care of factors like the latest trends and patterns in the regulatory industry. We have been pointing out again that in order for RI to be effective, it is necessary to keep up with latest changes in regulations and guidelines. Thus it becomes apparent that this process may go through multiple modifications to screen out the obligatory outcome.
- Regulatory Strategy
The key purpose to perform the above stated undertakings is to come up with the most appropriate and practical regulatory strategy for a company. Different products have different regulatory guidelines in different countries. This is why experts propose a plan of action that outlines an approach as to how to go about regulatory actions for the target distribution markets. However this plan of action is never a task done. It continuously goes forward as the mandates in the regulatory space change.
Why do you need RI Consultancy?
The context of regulatory operations gets more intricate with more products coming into existence and more updates ruled out by FDA and HAs. As a result it becomes difficult for pharmaceutical and life sciences companies to abide by these guidelines and regulations.
On a common front this is why companies fail to have successful regulatory submissions to the authorities:
- Keeping up with persistently changing rules and regulations by regulatory authorities is challenging
- Revenue loss if the compliance does not adhere to any of the regulations
- Knowledge gap in understanding submission rules and local regulatory policies as per regional requirements
- Need of extensive research and analysis that demands both time and resources
Implementation of Regulatory Information
Now that we are aware of how is RI implemented, we should also recognize how it helps an organization in terms getting things right for regulatory compliance.
RI activities assist organizations to:
- Update regulatory intelligence along with corporate intelligence
- Understand the marketing impact when a change takes place
- Identify the “hot button” issues that are widely quoted by FDA during inspection and be ready to overcome them
- Be familiar with insights of the market trends in regulatory space
- Decrease time to approval
- Potentially cut down the cost of product development through risk analysis
- Maximize of target markets
- Evaluate/ review conclusions to categorize trends and compare the outcomes of the process
Overall Influence of RI
Having talked about all the major standpoints of regulatory intelligence, it can be assumed that a virtuous regulatory strategy is an outcome of precise and well analyzed information of regulatory norms. The impact of RI doesn’t only effect the regulatory operations but also results in designing a wide spectrum of business portfolio for organizations.
Letting professional experts to put their minds on RI practices supports organizations to save on their time, resources, development overheads, chances of rejection from HA’s and most importantly their ROI. It ultimately helps an organization to be active and have a strong existence in the current pharma and life sciences segment.
With Regulatory Intelligence systems efficiently navigating the constant shifts in the Regulatory landscape while reducing the time-to-approvals and allowing more and more innovative drugs to reach the patients at the right time, it has become critical that Regulatory professionals as well as organizations must adapt to it at the earliest.