Melbourn Scientific has added a Proveris SprayVIEW system and Vereo actuator, making the contract research organization the first in Europe to offer cGMP spray pattern and plume geometry measurements required for nasal spray and MDI approval for the US. The company provides a number of analytical and formulation services for OINDPs.
Proveris Scientific Chief Commercial Officer Zach Pitluk commented, “It is with pleasure that I announce that Melbourn Scientific is to be the first European CRO to offer a FDA accepted spray pattern and plume geometry analysis service based on Proveris’s SprayVIEW instrumentation.”
“Instrumental spray pattern and plume geometry analysis is already a regulatory requirement for products aimed at the US market and it provides another level of information above particle and droplet size characterization,” said Melbourn Scientific CEO Mark Hammond. “We were the first CRO based in Europe to invest in the Malvern Spraytec for laser diffraction and the product and device development companies we support have found this service highly beneficial. It was following interest from these clients that we decided to extend our portfolio to include spray pattern and plume geometry measurement, using Proveris’s SprayVIEW. ”
Hammond added, “We are delighted to be working with Proveris to help accelerate the success of nasal and aerosol drug development and give our clients confidence that these test platforms are collecting valuable data with the accuracy, security, and traceability required for regulatory approval.”