Key Regulatory Trends to look out for in 2021

The Global Regulatory Information Management System (RIMS) market was valued at US$ 797.2 million in 2018, with a projected yearly CAGR of nearly 14% from 2019 to 2027. The biggest driver for growth in this sector is that certain regulations and requirements are country specific and may be different across different regions. Though certain countries may use a common technical document, there are certain constructs and nuances that need trained experts to help sieve through for successful regulatory compliance.

Divergent markets have varied complexities and diversity in regulatory requirements. Irrespective of whether the move for expansion is from a small emerging region to a well-established mature market or it’s from an established market looking at growth in an emerging region, there are certain regulatory compliance challenges that need to be addressed.

Navitas Life Sciences’ rimREADY provides robust support for evolving regulatory requirements

rimREADY helps in gaining competitive intelligence, using local and international expertise and experience. Engaging early and utilizing the right scientific advice will help in significant saving on time and cost.

4 Key Regulatory Compliance Trends to look out for in 2021

1) COVID-19 Vaccination Data and Adverse Events Reporting: COVID-19 resulted in unprecedented changes to normal life, but science helped in controlling its spread with the development of multiple vaccines. The current vaccination drive is one of the biggest in the history of mankind, and with the number of people getting vaccinated, experience and expertise is required to manage adverse event reporting.

Navitas Life Science tapped into its years of experience and expertise to seamlessly support the regulatory needs of a global pharma during the COVID-19 pandemic in 2020, leveraging our ability to rapidly mobilize our resources. The regulatory experts at Navitas Life Sciences assess the changing regulatory landscape, taking a holistic approach to regulatory management to enhance public health.

2) Digital Technology for Health and Medical Devices: Digitally enabled health devices like wearables have been growing in presence significantly. Such devices can generate large volume of health information, analyzing and transmitting the data using the Internet of Medical Things (IoMT). This is one of the fastest growing sectors and is expected to grow to $158 billion by 2022.

The digital health technology and associated devices may revolutionize health with their ability to track people with certain health conditions, but the regulation of such data and devices is key. The advent of interoperable devices and remote monitoring practices are examples of such risk environments.

In a typical Regulatory Information Management process both internal and external stakeholders contribute to ensure that the vulnerabilities and unique risks of the device are identified.

Navitas Life Sciences’ End-to-End Regulatory solutions help biopharma and medical devices companies manage submissions as well as product registrations tracking and maintenance across regions, functions, and partners. A robust set of tools and processes have been structured together by experts to manage the evolving regulatory requirements and to process data efficiently.

3) Real World Evidences: Real-world evidence is growing to be an effective and efficient method of aggregating data. A survey conducted by The Deloitte Center for Health Solutions found that 90% of respondents were interested in real world evidence capabilities but only half of them were mature enough to meet current challenges.

Life sciences organizations often lack the infrastructure, systems and the capabilities to collect and aggregate data, and the ability to oversee complex relationships that exist in the life sciences space.

To address these complexities, Navitas Life Sciences draws on successful strategies, and industry insights obtained through our networks to provide customized solutions for our clients.

Be part of our global RIM network with exclusive access to:

• Spring and Autumn in-person meetings in US and Europe; industry leading insights with a strategic focus
• Technology showcase events driven by member cases to discover cutting edge utilizations of technology, new approaches and collaborations
• Hot topic based industry working groups, think tanks and webcasts
• Member-only platform for collaboration and resource hub – a secure portal to connect and collaborate with peers and share the latest documented insights
• Live scientific community discussion board: connect with other members, post and answer questions on latest RIM topics
• Unique networking with access to Subject Matter Experts within Navitas Life Sciences
• Routine publications including white papers and discussion summaries

4) Artificial intelligence in Compliance Reporting: Artificial intelligence has been steadfastly enhancing various aspects of drug development, from product identification, clinical trials to regulatory compliance.

As the pressure for regulatory compliance increases with increase in complexity, there is a need to develop AI systems to

• Increase data being reviewed
• Increase audit frequency
• Identify potential compliance risks

Currently, the use of AI in compliance is important but it is not capable of resolving all issues. Technology is utilized to enhance processes and to build efficient systems that better manage regulatory compliance.

The life science industry is changing constantly, along with the regulatory landscape, adding new considerations for compliance. In certain countries, the governing regulatory bodies responsible for regulating safety of a product or a therapeutic compound may pose unique requirements and pricing models. Due diligence and a proactive culture is required to ensure compliance.

The confluence of an ever-changing industry environment and renewed regulatory requirements necessitate enhanced regulatory information management systems that will aid in efficient and effective path to compliance. rimREADY is an innovative regulatory information management system that ensures accurate and on-time submissions.

To learn more about rimREADY, access our latest brochure.