Regulatory Submission Support
Bringing a successful OINDP to market requires complying with and understanding global regulations. We can help.
Our approach provides more reliable product testing with fewer queries from regulators resulting in faster approvals. The Proveris by Design process establishes the effects of Critical Quality Attributes (CQAs) that are crucial for developing accurate and robust test methods required for regulatory approval of OINDPs.
Increase the predictability of meeting bioequivalancy goals.
Our studies are specifically geared to promote the understanding of the similarities and differences between a generic and a branded version of an OINDP. This understanding leads to knowledge driven decision making throughout the development cycle for the generic product, saving valuable time, money, and resources. The methodologies built into a Proveris by Design process study can provide insight into the viability of a product or efficiently drive changes before critical decisions are made that could adversely affect commercial success.
Simplify the development cycle of combination devices.
The structured nature of the Proveris by Design process is geared towards efficiency and simplicity. Through robust experiment planning and quantitative data analysis, we can help solve the complexities of OINDP development and bring better products to market faster and cost effectively than ever before.
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From a Proveris Sales Associate