All You Need to Know About Regulatory Strategies

by | Sep 13, 2021 | Compliance, Consulting Group, FDA, Health Canada, Healthcare, MedTech, Quality, Quality Systems, Regulatory


‌ 

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.

Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

Process Validation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?
The Role of Management in Product Quality

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system.  21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1]  The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.
Corrective and Preventive Action

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

Ready to learn more about working with us?

Pin It on Pinterest

Share This