“Having SME status will allow us to partner with both new and existing customers looking to expand into the region leveraging our regulatory services, which will help us accomplish our goal of getting new medicines to as many patients as possible.”
DEDHAM, Mass. (PRWEB)
March 29, 2023
Clinical and regulatory consulting firm Synterex, B.V., a wholly owned subsidiary of Synterex, Inc., has been granted Micro-, Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency’s (EMA) SME office.
This newly granted SME status would allow Synterex access to early and frequent regulatory interactions during drug development for human and veterinary medicines. Additionally, Synterex would be eligible for other incentives such as multi-language translation of regulatory documentation required for market authorization and potential fee reductions or waivers.
“The support that the EMA provides for SMEs will greatly benefit Synterex as we continue to expand our operations across Europe,” said Synterex President Jeanette Towles. “Having SME status will allow us to partner with both new and existing customers looking to expand into the region leveraging our regulatory services, which will help us accomplish our goal of getting new medicines to as many patients as possible.”
The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options. Detailed information on SME status can be found here.
For more information on Synterex, please visit http://www.synterex.com or join the conversation by liking and following us on the company’s social media channels: Twitter and LinkedIn.
About Synterex, Inc.:
Synterex is a WBENC-Certified Women’s Business Enterprise and disability-owned global clinical and regulatory consulting firm that provides clinical development solutions.
Delivering quality regulatory documentation requires navigating an evolving landscape influenced by regulators, research committees, healthcare professionals, and—most importantly—the scientific method itself.
At Synterex, we forge lasting and meaningful relationships that flex with the dynamic nature of science and technology.
Our staffers are seasoned and dedicated, with extensive experience doing the work hands-on as well as building and leading teams. We are committed to applying our years of experience and current subject matter and technical knowledge to help clients deliver important new therapies to patients in an expedient manner.
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