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:



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



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

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
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. 

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