Pharma cos use predictive models of regulatory intelligence to streamline product development, RnD spending: Experts

Mumbai, March 1, 2023 :

Companies are today using predictive models of regulatory intelligence to streamline their product development, business and R&D spending. Also, regulatory intelligence has gained significant importance with increasingly global considerations for product development, clinical trials and submissions to ensure market access in key regions, according to experts.

“Regulatory intelligence can help the pharma companies to capture global business opportunities. It predominantly helps to reduce the regulatory failure risks, helps for faster approvals, and manages the cost and time impact of global regulatory changes,” informed Santosh Savarkar, head, Umedica Laboratories Pvt Ltd while speaking on the sidelines of 22nd IDMA-APA Pharmaceutical Analysts Convention (PAC) 2023 held between February 24 and February 25, 2023 in Mumbai under the theme “Towards Creative Global Compliance.”

Regulatory intelligence thus allows companies to identify gaps in the registration dossiers, Technical concerns and trends, which focus and help on proactive compliance. It identifies and substantially eliminates high-risk areas which helps prevent rejections, fines and / or delays in approval. It also empowers businesses to make faster and appropriate better business decisions. Therefore, having correct regulatory inputs of knowledge helps an organisation to file quality dossiers responding to the market, legislative and competitive demands precisely.

“Within regulatory affairs, there is a substantial increase in the volume of available datasets. The challenges in this changing regulatory landscape are rapid increase in the number of drugs under observation and continuously evolving standards and scientific guidelines by regulatory agencies. Consequently, the amount of data that needs to be searched and analysed has increased exponentially,” Savarkar added. 

He further explained that life science regulations are a bit complex and the amount of data that needs to be analysed is huge. Regulatory submissions and compliance to the regulatory guidelines is highly dependent on facts. How and whether the organisation and its technical teams are well informed about changing regulatory requirements? Here comes the need of keeping the database, keeping track of amendments and new guidelines issued by various agencies. In order to manage this and keep technical and regulatory teams well informed about changing regulatory expectations is something which is dealt with through regulatory intelligence.

The regulatory intelligence team is tasked with providing strategic inputs to ensure regulatory compliance. It is equipped to fulfil the changing needs of various departments within the company and by senior leadership through strategically analysing relevant regulations and product competitive landscapes.  The regulatory intelligence function can have many applications within regulatory affairs and within the company but also has a key role to play in designing appropriate regulatory strategy for targeted market filings and registration.

Savarkar further explained that almost all pharma companies are under pressure to monitor the changes happening in the regulations and agency approaches. They have the onus to respond with technically justified answers to the queries. Hence, deep insight, Promptquick, accurate data analysis and timely interpretation and timely publication are critical towards a multitude of business benefits.

In the current dynamic regulatory environment, regulatory intelligence is specifically about monitoring, gathering and analysing publicly available and experience-based regulatory information. This is used to design, execute the development and filing strategies to save time and cost on development. It is also focused to reduce the number of assessment cycles to fast-track the approvals of submitted marketing authorisation (MA) applications.

“Regulatory intelligence is not just information, knowledge and data management. It is also about the skills or “intelligence” to conduct an impact analysis and disseminate acquired knowledge to build regulatory strategies for development, execution and filing till approval of the product. Regulatory intelligence adds value to the acquired information and helps to shape the environment to create a competitive advantage,” Savarkar concluded. Pharmabiz