What’s On Your Mind?
Proveris Scientific recognizes that different responsibilities prompt different questions when a spray or aerosol drug product developer is considering its test platform options. Investment in a new drug product is significant and receiving answers to these different questions at a stage where return on that investment can be realized sooner rather than later is crucial. While we provide below very general answers to questions our customers have asked, please feel free to contact Proveris for in-depth answers to any questions you may have.
Executive – How can Proveris improve the bottom line?
Proveris’s patented test process for spray and aerosol drug development, Proveris by Design™, has accelerated the success of new drugs. Organizations that have worked with Proveris from the beginning of the process to regulatory submission have reduced overall development time by 12 to 18 months – adding millions of dollars back to the bottom line. Moreover, on-going compliance with release testing requirements has been streamlined, thus reducing time to market and increasing return on investment. Please contact Proveris for more information about how the Proveris by Design™ process can accelerate the success of spray and aerosol drug development.
Quality Control – How can Proveris help us control the quality of our product?
Proveris’s spray and aerosol drug test platform is premised on enabling our customers to meet regulatory guidance and produce the most reliable drug product they can. Proveris’s patented Viota® software platform provides organizations with complete testing traceability for all tests performed with Proveris instrumentation and enables organizations to comply with 21 C.F.R. Part 11 for electronic records. Moreover, Proveris performs and documents installation and operational qualification when deploying the Viota software platform and all Proveris instrumentation. Proveris’s focus on quality and reliability is evidenced by its certification to the ISO9001: 2000 standard. Please contact Proveris to learn more about how Proveris can help organizations meet regulatory and quality standards for their spray and aerosol drug products.
Laboratory – How can Proveris help us meet FDA guidance for testing?
Proveris pioneered automated spray testing. Our patented SprayVIEW® instrument established the standard now recommended and used by the FDA for automated spray pattern and plume geometry testing of spray and aerosol delivered drugs. Our patented Vereo® automated actuators reliably replicate hand use of nasal and oral spray pumps and metered dose inhalers. Our Indizo® high through-put instrumentation provides automated routine dose content uniformity and shot weight testing. Our patented Viota software platform unifies test methods and data collected with all Proveris instrumentation. Please contact Proveris to learn more about how Proveris’s test platforms can accelerate the success of spray and aerosol drug development.
Proveris developed its Viota software platform to work within global, corporate enterprises. Its Oracle® Corporation back-end allows the Viota database to sit comfortably within secured networks while providing authorized users with access to all spray test data. Proveris’s deployment teams collaborate with IT departments for seamless software installation. They also provide guidance on integration with existing networks. Please contact Proveris to learn more about how the Viota software platform can work within your organization.