Key takeaways:
- RegASK’s AI-driven platform uses machine learning, specialized large language models, and agentic AI to automate and streamline regulatory tasks.
- This approach helps global companies across pharmaceuticals, biotech, and cosmetics stay compliant more efficiently by improving accuracy.
- RegASK’s partnership with Esko connects regulatory intelligence with packaging development tools, enabling design and content compliance.
We all know that life sciences is one of the most tightly regulated industries because its products directly affect human health and safety. These regulations extend beyond product development and manufacturing—they have a significant impact on packaging and labeling as well. Navigating these complex and constantly evolving rules can be challenging. Yet, non-compliance isn’t just inconvenient—it can lead to product recalls, legal penalties, or even harm to patients, making regulatory accuracy critical.
“Compliance with regulations such as the FDA’s labeling requirements, ISO standards for sterile packaging (e.g., ISO 11607), and anti-counterfeiting directives requires extensive documentation, rigorous testing, and careful oversight. Failure to comply can result in severe consequences including product recalls, significant fines, market restrictions, and damage to brand reputation,” says Amen Reghimi, CTO at RegASK, a leading provider of AI-driven regulatory intelligence.
RegASK is an AI-driven regulatory technology company that offers a cloud-based SaaS platform to help businesses—especially in consumer goods, life sciences, pharma, cosmetics, food, medical devices, and more—manage global regulatory compliance efficiently. To address the new and evolving regulations within the industry, and streamline packaging development, RegASK recently partnered with Esko, a global leader in integrated software and hardware solutions for packaging and labeling. This partnership aims to help brand owners and packaging teams stay on top of regulations, reduce the risk of compliance issues, and save time by cutting down on manual checks and updates.
“Brands across highly regulated industries, including pharmaceuticals, biotech, medical devices, food, nutrition, cosmetics, and personal care sectors, are adopting AI-driven regulatory intelligence solutions,” says Reghimi.
It’s because these organizations typically have extensive global operations, complex product lines, and stringent compliance obligations. AI solutions like this one help to streamline regulatory tasks, improve compliance accuracy, and efficiently manage risk. RegASK’s solution uses machine learning to deliver clear, up-to-date regulatory information. Working with Esko, this solution connects regulatory know-how with packaging tools to make sure designs and content meet requirements from the start.
“RegASK uses advanced AI methodologies, notably machine learning, vertical large language models (Vertical LLMs), and agentic AI solutions. Vertical LLMs are specialized AI models tailored to understand and analyze complex regulatory language specific to industries like life sciences and consumer goods. Agentic AI proactively automates routine regulatory tasks, such as data extraction and compliance monitoring. Whenever ambiguities arise, a human-in-the-loop process ensures regulatory accuracy, refining the AI over time,” says Reghimi.
The machine learning is capable of delivering up-to-date information that will help brands keep up with changing rules in different markets globally. The AI-driven framework is designed to integrate seamlessly with existing regulatory and operational workflows and will ultimately help companies get their products to market faster.
“RegASK’s AI-driven regulatory intelligence solution accelerates time-to-market by streamlining and orchestrating the regulatory review process. By significantly reducing manual workload, including documentation, labeling verification, and regulatory monitoring, RegASK delivers efficiency improvements of approximately 30-50%,” says Reghimi.
