Product Development Consulting

As a global leader in medical device, pharmaceutical, and biopharmaceutical consulting, EMMA International has the expertise to help you overcome challenges and speed up product development. Whether you need guidance through the entire product development cycle or assistance with one area, EMMA International will design a solution to meet your needs.

EMMA International partners with laboratories and R&D centers worldwide to support the research and development of your product. From running developmental in-vitro assays, to conducting in-vivo testing, to software design, EMMA International has the people and resources to move your product forward. By performing the quality and regulatory work in unison, we ensure compliance at every step.

Our services include the following:

 

Pharmaceuticals

Know what type of submission your drug requires, the type of testing required, and other questions that you may have. Our regulatory strategy service will answer questions about the applicability of the following to your product:

  • Pre-market submissions
  • Pre-submissions
  • Clinical investigations
  • Types of safety and efficacy studies.
  • Global requirements for market entry

 

Biologics

It can very challenging and overwhelming to deal with the regulatory landscape in commercializing products of complex structures such as biologics. Our regulatory strategy service will lay out the applicability of the following to your product:

  • IND
  • IDE
  • Pre-submissions
  • BLA submission
  • Global requirements for market entry
  • Other prerequisites to getting your product to the consumers

 

Medical Devices

Several factors such as the class of the device, availability of predicate devices and the technology drive the route to market approval for medical devices.

With our regulatory strategy service, you will know the device classification of your product, predicate devices, if available, and the applicability of the following to your products:

  • Type of submissions required such as 510(k), PMA, De Novo, HDE,
  • Performance testing requirements
  • International performance standards
  • Global requirements for market entry

To move your product through development more efficiently, with guaranteed compliance, get in touch with one of our experts.

Ready to learn more about working with us?

Product Development Resources

FDA Adverse Event Reporting 

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

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

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?

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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