In the medical technology world, it is becoming more and more difficult for medical devices and products to be and stay compliant with the FDA’s regulations. The US is just one market; many organizations and devices are distributed internationally, including the EU and Canada, which are the most common markets. How do companies know all the different regulations of each market? The answer: a regulatory strategy.
A regulatory strategy outlines a pathway from research and development to interstate commercialization while staying compliant with the intended market’s regulations and policies. Additionally, a regulatory strategy outlines a potential budget from that research development stage all the way to the commercialization of a product or device in a particular market.
A pharmaceutical regulatory strategy helps clarify the type of submission and testing that a drug product requires. In this type of regulatory strategy, our consultants outline pre-IND and IND submissions, clinical investigations, pre-market submissions, and any requirements for market entry.
In our biologic regulatory strategy, our consultants lay the groundwork for expanded access, BLA submission, and other prerequisites to getting the product into interstate commercialization. Our consultants are highly skilled in knowing the development and the different regulations for biologics.
With our medical device regulatory strategy, consultants will provide a clear understanding of what medical agencies are wanting to see in an organization’s submission. Knowing that a class of a device, availability of predicate devices, and the technology all factor into medical device clearance or authorization. Our consultants also advise on the type of submission required, performance testing requirements, international performance standards, and any global requirements for market entry.
Is your organization ready to get a medical device or product on the right path to approval? Reach out to one of our consultants today at info@emmainternational.com or call us at 247-987-4497.
