Theorem Clinical Research, the US-based provider of clinical research and development services, has boosted its resources in regulatory consulting and medical devices/diagnostics through a strategic partnership with Emergo Group.
With headquarters in Austin, US, Emergo is a regulatory consultancy offering a wide range of compliance and market-access services in 25 countries.
The group has more than 2,500 clients in the medical and in vitro diagnostic device sectors, helping them with global regulatory strategy, device registration, quality-management system compliance, in-country regulatory representation and distributor qualification.
Under Emergo’s agreement with Theorem, the two companies will provide global regulatory consulting services, including reimbursement consultation and in-country regulatory representation, to the medical device and in vitro diagnostics community.
D. Lee Spurgin Jr., senior vice president and general manager of medical device and diagnostic development at Theorem Clinical Research, said Emergo complemented Theorem’s own global strategic regulatory affairs and clinical-trial capabilities.
“Working together we can provide more services and a bigger global footprint so our strategic relationship helps us to be a one-stop provider for our clients,” Spurgin added.