Regulatory Intelligence & Strategy
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.
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
Conclusion
The dynamic and advancing approaches for RI lifecycle management have been critical in accelerating the pharmaceutical product development and approval. The development of strategic data sourcing, aggregation, and application of regulatory intelligence can be the key to success for any drug or device development.
With their respective expertise and knowledge, Regulatory and technology professionals play a pivotal role in the success of the entire process. An efficient RI team enables seamless strategic planning and execution toward achieving the overall goal of making safe and efficacious medicines available, in a timely and regulated manner to patients across the globe.
