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

Investigational Device Exemption

Investigational Device Exemption

An investigational device exemption (IDE) allows for investigational devices to be used in clinical studies to collect the proper safety and effectiveness data....
Concepts of Modern Quality systems

Concepts of Modern Quality systems

A quality system's main purpose is to consistently produce safe and effective goods while also guaranteeing that these actions are sustainable long term. It should be emphasized that putting in place an effective quality system in a manufacturing company will take a substantial amount of time and effort. By incorporating effective knowledge-building methods into day-to-day operations, a strong quality system will improve...
How to Submit a 510K

How to Submit a 510K

Three types of Premarket Notifications can be submitted to the Food and Drug Administration (FDA) Traditional, abbreviated, and special 510Ks. The traditional 510K program is utilized to seek marketing authorization for any device. When submitting a 510K there is not a form to submit however submission requirements can be found under 21 CFR part 807.

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