The Future of Regulatory Services: Trends and Predictions for the Industry

It is important to break down and grasp the megatrends that are affecting industries worldwide. While these can be relatively dynamic, versatile, and complex, understanding such trends can support pharmaceutical regulatory affairs professionals in navigating the impact these trends will have on their roles, responsibilities, and work that they do on a daily basis which would drive the pharma and healthcare industries. Some of the key trends include:

·       Leveraging technological disruptors such as artificial intelligence (AI), and real world evidence (RWE) in regulatory processes.

·       Automating regulatory tasks such as regulatory intelligence, regulatory information management etc to ensure regulatory compliance.

·       Real-time regulations.

·        Exploit opportunities for global harmonization of e-submissions and support harmonization/convergence between regulatory authorities.

From maximizing diversity in clinical trials to incorporating patient voice and real-time data for making enhanced regulatory decisions, the future of regulatory affairs is looking technology-driven.


Trends in Regulatory Outsourcing

Outsourcing of services for drug development and commercialization is on the rise, including regulatory services. Indeed, for regulatory affairs, the global outsourcing market is set to reach $14.9 billion by 2028, with a compound annual growth rate (CAGR) of 11.9% from 2021 – 2028. A significant part of this growth is attributed to the increase in fixed costs of in-house regulatory affairs operations.

Larger pharmaceutical companies are using functional services partnerships (FSPs) as they lower sponsor drug development costs by decreasing redundant activities, providing expertise that can be scaled up, and providing flexibility in resources. Furthermore, reduced burden on operations and resources, as well as more simple finances, are some of the key benefits.

Which Model?

The 2 main models of outsource are the FSP and the full-service offer (FSO) where the latter usually involve a single project with many services, and includes project management of the particular study. Whereas an FSP model involves multiple projects for a single service which could be regulatory, pharmacovigilance, medical writing, etc. The 5 main types of FSP models include:

  1. Fixed price model
  2. Unitised models
  3. Output or performance based models
  4. Full time equivalent model
  5. Time and materials model 

Indeed, strategic approaches are required to progress through product development- from pre-clinical stages to post-approval activities. It is important for regulatory consulting organizations to evaluate client portfolios and resources in the market, and then figure out the best solution that would facilitate high quality deliverables for a project. It is important to note that a successful partnership also relies on a robust governance structure which should be tailored around client requirements. 

FSP models provide many benefits for regulatory affairs outsourcing due to their flexibility and customization towards clients. Regulatory workflows are managed more efficiently which increases capabilities and allows in-house resources to be freed up. The regulatory environment is dynamically evolving as clients look to obtain regulatory solutions that address their needs, while ensuring compliance. Regulatory service providers should ensure they stay aware and updated of megatrends that could revolutionize operations which would take regulatory affairs and pharmaceutical industry to new heights. 


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