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.

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Regulatory Strategy Resources

FDA Adverse Event Reporting

When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public.

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

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