Regulatory Strategy Consulting

Get answers and get your product to market. A regulatory strategy from EMMA International gives you a detailed, holistic view of your regulatory pathway from research to commercialization. You’ll not only have the information needed to keep your regulatory submission timeline on track, but also have the data to create your budget.

EMMA International’s regulatory experts—many of which are former FDA officials or regulatory affairs executives—advise on pharmaceutical, biopharmaceutical/biologic, and medical device strategy for U.S., EU, Asia Pacific, and other regulatory bodies. We’ll unmask the unknowns on your journey to commercialization and streamline the submission process.

Pharmaceutical Regulatory Strategy

We’ll help clarify the type of submission and testing your drug requires. Our regulatory consultants are available to answer questions about the following:

Pre-IND and IND
Pre-market submissions
Pre-submissions
Clinical investigations.
Global requirements for market entry

Biologic Regulatory Strategy

The development and regulations for biologics are both highly complex. Our regulatory strategy lays the groundwork by consulting on these and other aspects:

Pre-IND and IND
Expanded access
Pre- market submissions
BLA submission
Global requirements for market entry
Other prerequisites to getting your product to the consumers

Medical Device Regulatory Strategy

The class of a device, availability of predicate devices, and the technology all factor into medical device clearance or authorization. With EMMA International on your side, you will gain a clear understanding of what regulatory agencies want to see in your submission. We also advise on the following:

Type of submission required (IDE, 510(k), PMA, De Novo, HUD & HDE)
Whether you should apply for FDA Breakthrough Device Designation
Performance testing requirements
International performance standards
Global requirements for market entry

Ready to get your product on the right path to approval? Talk with EMMA.

Ready to learn more about working with us?

Contact Us

emma-international-ready-to-learn-more@2x

Regulatory Strategy Resources

The End of the COVID-19 Public Health Emergency

After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.

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

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

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.

See All Resources