Strategizing Artificial Intelligence in Regulatory Affairs and Pharmacovigilance

By reimagining regulatory submission strategies with artificial intelligence in regulatory affairs, pharmaceutical companies can expedite timelines and boost their chances of successful product approvals.

To accelerate the market entry of new products, there is a need to increasingly focus on regulatory submissions as a critical area for developing strategic capabilities. The submission process is a multidisciplinary effort requiring meticulous coordination across phases to formulate a filing strategy and prepare the dossier for regulatory review.

At Navitas Life Sciences, we define submission excellence as the ability to create high-quality regulatory submissions within industry-leading time frames. These submissions must accurately represent relevant data and maximize the likelihood of first-time approval with a favourable label for medical products. Achieving submission excellence benefits both patients and the pharmaceutical industry as faster product launches reduce waiting times for life-enhancing therapies.

Comprehensive Regulatory Affairs Services

A strategic partner with deep expertise on global regulatory affairs and a forward-thinking approach will aid in enhancing the regulatory submission process. Navitas Life Sciences provides a full spectrum of regulatory affairs services and regulatory affairs consulting designed to support pharmaceutical companies from development through post-marketing stages with regulatory time-to-market edge.

Flawless Reg Submissions

Our End-to-End Global Regulatory Affairs services include:

• Regulatory Submissions Management : Gain complete oversight of your product life cycle with quality and compliance
• Labeling and Artwork Management : Global & local label management, and artwork management
• Regulatory Information and Data Management : Leverage our strategic path to RIM excellence
• Regulatory Compliance Management : Our precision regulatory solutions help identify quality issues and ensure patient safety
• Regulatory Resourcing : Access our best regulatory affairs consultants as per your business requirements

Advanced Pharmacovigilance Services

Ensuring patient safety and compliance with global pharmacovigilance regulations is paramount. Navitas Life Sciences offers robust regulatory and PV services, integrating artificial intelligence in pharmaceutical regulatory affairs to enhance efficiency and accuracy.

Our PV services include:

• Strategic Safety Consulting : Implement the right sourcing strategy and ensure global compliance by engaging our consultants
• Safety Industry Networks : Better manage safety risks through insights gained from our networks
• End-to-End Pharmacovigilance Services : Improve operational efficiency and ensure compliance with our full-service operations
• Pharmacovigilance Technology : Leverage technology to meet your needs and budget

Leverage our Precision Regulatory Solutions

Insights from Marty Boom: The Future of Gen AI in Life Sciences

Marty Boom

Global Head of Regulatory & PV,

Navitas Life Sciences

Our Global Head of Reg. & PV, Marty Boom, is a seasoned expert with over two decades of experience in regulatory affairs, pharmacovigilance, and management consulting. Recently, he explored the targeted applications of Gen AI, and the use of artificial intelligence in pharmaceutical regulatory affairs in his enlightening article for PharmaFocus Europe.

We had the opportunity to sit down with Marty Boom to discuss the transformative impact of Generative artificial intelligence(AI) in regulatory affairs and pharmacovigilance.

How has Generative AI impacted pharmacovigilance and regulatory affairs in the life sciences industry?

Generative AI has significantly optimized workflows in pharmacovigilance and regulatory affairs, allowing for the automation of routine tasks and enhancing data analysis capabilities. This has led to increased efficiency, accuracy, and faster decision-making, ultimately improving regulatory compliance and patient safety.

Please share insights into how Generative AI has transformed adverse event reporting and improved patient safety or reporting accuracy?

Generative AI in regulatory affairs has revolutionized adverse event reporting by enabling automated case creation from unstructured data, improving the generation of case narratives, and facilitating prompt follow-ups. These advancements ensure more comprehensive and timely reporting, which enhances patient safety and reporting accuracy.

What emerging trends or innovations in Generative AI do you believe will further revolutionize PV and regulatory affairs?

Emerging trends in Generative AI that will further revolutionize PV and regulatory affairs include the use of AI for early detection of safety signals, the development of nearly touchless PV case processing, and the auto-generation of regulatory reports and narratives. These innovations will lead to more proactive safety management and streamlined regulatory processes.

Gen AI and PV Regulatory Affairs

Gain valuable insights into how AI in regulatory affairs is reshaping the life sciences industry

Explore transformative potential of Generative AI in pharmacovigilance and regulatory affairs.

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Navitas Life Sciences is committed to driving innovation and excellence across phases, including in regulatory affairs and pharmacovigilance. Partner with us to leverage the power of Generative AI and transform your regulatory and safety processes for superior outcomes.

Contact us today to learn more about our regulatory affairs services and how our regulatory affairs consultants can support your journey towards faster market reach.

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