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

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

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