Regulatory functions such as submission and publishing, regulatory intelligence, labeling, etc. are intricate areas of the regulatory spectrum that are ever evolving. There is no doubt to the fact that some real time challenges are involved in submission processes especially now when the world is shifting from paper to electronic submissions. For pharmaceutical and life sciences companies to be able to smoothly distribute their product line in different geographies, huge volumes of data needs to be maintained. Based on this data, the submissions are made that ultimately affects the approval timelines.
Why Companies need a Dedicated Data & Information Management System?
Now let’s understand the key reasons behind health authorities demanding more and more information from companies. Well, the foremost reason is that regulatory authorities wish to have this information readily available at any instant of time. There should be a centralized location for all this data accessible from anywhere anytime. Since there are many perspectives involved in the review process by health authorities, this database helps the regulatory reviewers to be able to cross-refer any information regarding any medical product. There are other factors too that can be determined if companies have a regulatory data and information management system like:
- Details about what product has been registered in which region.
- Consequently, it also helps to analyze about how the health authorities work in that particular region/country.
- Whether all changes approved in one region are or need to be implemented in other regions.
A well-structured regulatory data and information strategy not only helps the health authorities but also allows companies to analyze and fill the gaps in their information which further helps to improve interactions and collaborations with partners and enhances business decision-making.
What’s at Stake?
With the technology that offers a huge pool of structured information about medical products of a company, comes the worry of failing to adhere to the regulations. For instance, regulatory controllers in Europe have authority by their legal framework to enforce severe permissions on companies that fail to comply with guided mandates or requirements. It is for companies to have an integrated regulatory data and information management system to be able to share the info such as registration details of the product line in various regions/ countries, lifecycle processes, marketing authorization approvals, change management implementations and any other updated information with the regulatory authorities to be approved. In European countries, any authorized regulatory individual representing a health authority organization should have direct access to all this information. The metrics associated with a strategic affect the brand image in the market.
- How has the company performed during submission and publishing process?
- How much time did it take for a company to get approvals?
- Was any of their product got recalled?
- How many amendments were involved in submission process?
Answers to questions like these help build a basic metrics on which a company is evaluated in the regulatory market.
Companies and regulatory experts need to understand that implementation of a strong and reliable data & Information system, directly and indirectly, affect all other regulatory operations and affairs. If there is a gap found at any instant, it will get reflected in some or the other regulatory processes. Since there are a lot of complexities involved in this particular execution, for companies, a reliable and innovative regulatory partner can help them go in the right direction.