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

Understanding Biosimilar Products

A Biosimilar is essentially a biologic product that is similar and has no clinically significant difference in terms of safety, purity, and potency from an existing approved Biologic on the market.

The FDA and AI/ML in Medical Devices: Navigating the Future of Healthcare

Artificial Intelligence (AI) and Machine Learning (ML) are revolutionizing healthcare, offering unprecedented opportunities to improve patient outcomes, streamline processes, and enhance diagnostic accuracy. As AI and ML continue to make significant strides in the medical field, the U.S. Food and Drug Administration (FDA) plays a pivotal role in regulating these innovations. In this blog post, we'll explore the intersection of AI/ML and medical devices, and how the FDA is navigating this rapidly evolving landscape.

The FDA’s Update to Biocompatibility Guidance

The FDA’s guidance document on the use of ISO 10993-1 was updated this month with some crucial information for medical device manufacturers. Biocompatibility testing has been a long-standing requirement for a majority of device manufacturers, so this update that includes some excluded materials and devices is a welcome change.

Mastering the Art of Medical Device Design Controls

Effective design controls are fundamental to producing safe and effective medical devices. They not only help ensure regulatory compliance but also contribute to the overall quality and reliability of the product. Continuous improvement and a commitment to robust design control processes are essential for success in the medical device industry.

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