Organizing raw test data into useful knowledge with actionable insights can further your FDA approval process and streamline manufacturing.
Our systematic approach incorporates a fundamental understanding of key components of Quality by Design (QbD): defining the goal, discovering the design space, testing the control space, and targeting the operating space. We are experienced in testing new product concepts and in performing bioequivalence studies that provide our customers with verifiable test methods and instrument settings.
During this control space study, we examined the range of demonstrated human actuation by testing shot weight, spray pattern, plume geometry, and droplet size distribution of the product to determine and confirm an optimal test method and automated actuation profile within the human range (as required by ICH guidelines).
As an example, the graph above highlights how the Proveris by Design™ process helps optimize method development and actuation parameter determination.
"Proveris Scientific Corporation provides expert support for nasal developers. They are fast, reliable and are professionals at installing of their equipment and supports in demanding challenges."
Dr. Peter Svete, Head of Physical Analytics, Lek Pharmaceuticals d.d.
"Proveris provides insightful and thorough test services. We would recommend working with Proveris. Proveris has great expertise in spray analysis."
Elaine Schutte, Chief Development Officer, ProFibrix
"I want to express my sincere gratitude towards Proveris and the service team for being there to make sure our study goes well. The study just completed few minutes ago and thankfully everything went well.......while we conducted SAC study. It was a great display of professionalism by Proveris."
"As customary, Proveris's service team provided excellent service and was able to answer my questions."
"Thank you for the thorough training on our new equipment. I wish more companies would implement your hands on approach when it comes to training. Thanks again."
“We really appreciate the creativity and work conducted at Proveris for their Test Services (Proveris by Design®). Their knowledge, experience, and insight with OINDP’s was very helpful. Thanks to the Proveris team, we have a wonderful solution that we can use for commercial products!”
Mic Iwashima, NDS Division, Shin Nippon Biomedical Laboratories, Ltd