Regulatory Compliance and Technology

Regulatory compliance essentially means making sure that all processes and activities are in accordance with, relevant legislations, guidelines, laws, and standards. This is important in regulatory affairs to make sure that all processes involved in pharmaceutical development- from pre to post market stages- are adhere to requirements and standards that would ensure safety, efficacy, & quality and minimize patient risk. Regulatory compliance is priority for all pharma regulatory affairs organizations and in-house departments as non-compliance can not only lead to patient harm but also product recall and subsequent business loss.

A business that can meet the standards and requirements that are set by regulatory authorities is also an aspect of regulatory compliance that is important, where certain operations, activities and even the organization’s employees are “in compliance” or not. It is also possible that an organization can be compliant with one set of regulations i.e., for manufacturing, but deficient in another i.e, employee safety. Thus, regulatory compliance can be conducted on several aspects depending on the function.

With regulatory requirements becoming more stringent and regulatory agencies detected more risks and bad practices there is added pressure to “do more with less” by cutting down load on resources and letting technology take over. Regulatory approval processes are complex and complicated, and are associated with heavy financial implications if they are not conducted appropriately. If a pharmaceutical product is rejected, it could take several months to years to be able to reapply, re-submit and get approval again. What doesn’t help is the low approval rate for pharma products; 1 in 6. Hence it is absolutely imperative to avoid any and all unnecessary rejections or risks of rejections.  

As of now, the majority of compliance activities that occur in pharma organizations are done manually and incorporation of technology is relatively new. However, as innovative technology, software, and databases advance and become more readily available, more organizations are incorporated them into their everyday regulatory service and compliance activities, and can vary depending on what function they are intended for. Technology can facilitate being able to keep up with large data sets and effectively translate compliance to a more value-adding function rather than it be cost-heavy.

Technologies such as natural language process (NLP) and/or natural language generation (NLG) are forms of artificial intelligence that have been used to generate policy applications and mine large & unstructured data to identify any red flags that could lead to risk of non-compliance within any operations. Databases and regulatory information management systems (RIMS) streamline and handle compliance processes that are related to various pharmaceutical and allied products. RIMS and associated software not only ensure that compliance processes are being handled appropriately, but it also a crucial part of regulatory affairs and regulatory consulting. They allow for regulatory compliance data to be in one system, on one platform, and can be easily accessed for all stages of the regulatory ecosystem i.e., clinical, non-clinical, manufacturing, distribution etc. RIMS ensures that all regulatory information being used is industry-ready and verified/validated, available on one platform, and reduces all risks of human error that could otherwise lead to rejection of the marketing authorization application.