WorldPath Regulatory Solutions helps innovators clear a path through global regulatory requirements. We work with teams that are determined to deliver life-altering diagnostics and therapies.

We rely on an experience base that stretches over decades and involves vast amounts of leadership across a wide range of regulatory submission activity with the most relevant agencies:

– U.S. Food and Drug Administration (FDA)

– Health Canada

– COFEPRIS (Mexico)

– ANMAT (Argentina)

– ANVISA (Brazil)

– The European Union (EU)

We also collaborate with various other regulatory bodies depending on your market strategy needs.

Our team's experience includes securing numerous first-of-their-kind clearances, including those for next-generation sequencing products and platforms—a type of product that is revolutionizing the healthcare paradigm.

Our team spans deep expertise across the areas of

– strategic submission planning and execution

– regulatory risk assessment

– market expansion programs

- Regulatory Information Management Systems (RIMS) adoption and the incorporation of AI tools into operations

One area of deep focus is aligning innovative regulatory pathways with your business model. We prioritize efforts that add the most value for you, including creating regulatory submission strategies, writing and defending submissions, conducting due diligence audits prior to acquisitions, and training teams on the fundamentals of regulatory submissions and some of the nuances that can enhance regulatory operations. We have ourselves worked in large multinational corporations and can apply our learnings from those experiences to your project. We’ve lived through what good looks like and struggled through messy operational paths. We’ve experienced firsthand what regulatory reviewers like (and what they don’t) in numerous countries. However, we value maintaining an approachable style and understand the importance of speed to market, not only for your bottom line but also for the improvement your innovations will bring to the lives of patients. This hands-on technical fluency sets us apart.

Our founder's AI Mastermind certification means we understand not just the regulatory side of life sciences but are also committed to understanding the technical side of machine learning, enabling us to help you create winning submissions.

We don't get bogged down in assessments of quality management systems; instead, we focus on regulatory submissions and operations and invest in digital tools to streamline and scale up everything we do. And we do it with style.