100% Commitment and uniquely positioned to help customers succeed in the OINDP market
For twenty years, Proveris Scientific has been focused on helping its customers deliver great orally inhaled and nasal drug products (OINDPs) to patients that need them. Our staff of professionals is rigorously trained through our ISO9001:2008 certified program and understands the nuances of OINDPs to help customers succeed. We are a true partner to our customers and strive to deliver value to them in everything we do – from developing testing strategies, to delivering and servicing their instruments, and to conducting method development studies.
Our core objective is dedicated to the OINDP market and working closely with generic and branded pharmaceutical companies, device suppliers, CDO/CMO/CROs, and global regulatory agencies. We do extensive product testing with our own applications team and laboratory to help us understand exactly the challenges our customers have in developing their products and successfully bringing them to market. We regularly present our findings at scientific conferences and regulatory agency meetings. These experiences allow our team to uniquely synthesize the complexities of OINDPs and deliver value-oriented solutions to our customers.
Proveris has dedicated staff and a network of sales and service professionals who are focused on customer success worldwide. Our team of professionals is here to help you at every step of the way: sales discussions, technical support, service, and product consultation.
The Proveris by Design™ process: the key to unlocking a successful product submission!
Our unique, patented process is a launch point because it identifies the human usage performance of an OINDP according to current FDA and ICH guidelines for in vitro testing. This process is highly interactive between our scientists and you, and normally results in our customers making comments like, “Now I know why we were experiencing such erratic performance from our product. We were in the dark for so long – thanks for opening our eyes!” And, “Now I know what changes we need to make to our OINDP to achieve bioequivalence and why!”
Some key benefits of the Proveris by Design process are:
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.|
|Our studies are specifically geared to promote the understanding of the similarities and differences between a generic and a brand 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 effect commercial success.||
Abbreviated New Drug Applications (ANDAs) failing to meet bioequivalence can be avoided.
Method development can be difficult, time consuming, and complicated.
|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 mysteries of OINDP development and bring better products to market more quickly and cost effectively than ever before.|