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?

Regulatory Strategy Resources

Analyzing De Novo Devices

Analyzing De Novo Devices

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn

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