Product Development Consulting

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.