Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety. Having said that, the need of the hour is to gain insight on ever-evolving market updates. Whether it is the recent announcement of cutting down major part of the FDA’s regulations, or warnings on data integrity violations, manufacturers must know the industry insights to pave a strong strategic Regulatory pathway. Today’s regulatory professionals must understand not only the regulatory guidance for each geographical market in the world, but also the hot-button issues that affect the review of new drug applications in these regions. With the globalization of life sciences industry making the regulatory landscape more complex than ever before, there is a growing need of intelligent Regulatory information services. Here we explain why…
What is Regulatory Intelligence?
Regulatory intelligence (RI) is relatively a new arm of global regulatory affairs (RA). Usually part of a biopharmaceutical company’s RA department, it broadens the traditional regulatory affairs function beyond preparing and submitting applications to the FDA and other regulatory agencies across the globe. The primary scope of RI involves keeping the company’s leadership up-to-date about current regulations affecting the development, approval, and maintenance of drugs/devices/cosmetics to updating them of any changes to the regulations that may impact their efforts.
RI also focuses on regulatory pathways associated with drug development and approval process, often using historic decisions of regulatory agencies to gauge potential future decisions. RI also contributes to every biopharmaceutical company’s bottom line by helping the RA teams provide the best quality submissions to agencies.
The Importance of Regulatory Intelligence
- Continuously changing regulations and increased liability: Change is constant and one needs to keep pace with it. In 2015 alone, 243 new guidance documents were issued, in comparison to only 117 back in 2012. In today’s pharma world, even a seemingly small shift in the business or regulatory environment can have huge ripple effects.
- Data-driven decisions: A study conducted by the MIT Centre for Digital Business revealed that data-driven organizations reported 4% higher productivity rates and 6% higher profits than others in the industry. Knowledge of these numbers significantly affect the overall bottom line of a company and hence is hard to ignore.
- Hard benefits: The most obvious Return on Investment (ROI) calculation is the cost savings created by eliminating manual processes. For example, an integrated RI system can help eliminate the requirement for a manually updated spreadsheet-based regulatory process, which is also liable to errors. An RI system accurately organizes all relevant documents into one research, thereby improving the visibility and accountability for all data-driven regulatory decisions.
- The ‘soft’ benefits: A decently set-up RI tool can extensively track competitor activity without requiring significant man-hours to do so. Not only will this lead to more productive research time, but would also let staff easily handle workloads and deadlines.
- Time saving: Keeping up to speed with the ever-changing global regulatory environment is vital to professionals involved in the clinical development, launch, and post-marketing surveillance of drugs. With many different sources of information, finding and analysing what you need for submissions and beyond is a time-consuming task. To make the right decisions for your organization, quick access to accurate information can make all the difference.
- Information analyses: Onlyknowing where to find the applicable regulation is not a regulatory consultant’s only service. They are hired to interpret those requirements, which is what regulatory intelligence is. It can be gained through experience working with regulatory agencies and companies developing novel products. Regulatory consultants, who spend a lot of time talking with regulatory agencies, understand current agency thinking. They also likely have gained useful knowledge from past projects contributing to reduced risk for the current client project.
In conclusion, change is permanent. Sailing with that or being ignorant makes all the difference. Regulatory change is viewed as a key component of organizations’ strategic planning process. To support your company with a single, comprehensive source for global regulatory information in order to make faster, more informed decisions, you need an industry expert with a dedicated Regulatory Intelligence discipline.