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New Product Development

Innovating to meet your clinical needs

Developing new products to meet your clinical needs is at the core of what we do

QuVa is committed to finding new and innovative ways to meet your clinical needs and support the best possible patient care and outcomes. Developing new products is a core capability of ours so you have the essential products you need.

QuVa has a robust Clinical Services group with a demonstrable history of product innovation and delivering development of products in shortage, or that our hospital partners have requested.

Products such as low dose Heparin, R.E.C.K, Buffered Lidocaine with Epinephrine, Potassium Chloride with Lidocaine, and our unique 2L Pharmacy Bulk Package for Bupivacaine and Ropivacaine to help pharmacies more efficiently process into end-use containers like pain pumps.

QuVa has also made great advancements in labeling, working with our customers to design clear and easy-to-read labels on our syringes that can be seen from all sides.

An Innovation Engine to Meet Clincal Needs

QuVa focuses its new product
development efforts on meeting
patient needs in three areas

1

Meeting an existing or emerging need for a ready-to-administer product

2

Covering a product listed on the FDA Drug Shortages list

3

Providing an alternative to a commercially available product based on clinical need.

4

Providing improved formulations of products–e.g., improved buffering systems; extended stability

step by step

New product development process

Research

Lead Pharmacist
Chemical Engineer
Clinical Drug Evaluation
Drug safety/ therapeutic evaluation
Initial formulation research
Finalize clinical drug evaluation, dosing, route of administration
Clinical fit evaluation
Regulatory evaluation

Development

Lead Pharmacist
Chemical Engineer
Protocol
Pilot Scale Batch
Testing Methods
Component Qualification

Launch

Change Control
Customer Portal
Communicate
Manufacture

Formulate

Lead Pharmacist
Chemical Engineer
Literature
Sourcing
Protocol
Lab Sample
Test Method Development

Validate

Chemical Engineer Pharmacist
Protocol
Process Validation
Stability Study
Test Method Transfer

Research

Lead Pharmacist
Chemical Engineer
Clinical Drug Evaluation
Drug safety/ therapeutic evaluation
Initial formulation research
Finalize clinical drug evaluation, dosing, route of administration
Clinical fit evaluation
Regulatory evaluation

Formulate

Lead Pharmacist
Chemical Engineer
Literature
Sourcing
Protocol
Lab Sample
Test Method Development

Development

Lead Pharmacist
Chemical Engineer
Protocol
Pilot Scale Batch
Testing Methods
Component Qualification

Validate

Chemical Engineer Pharmacist
Protocol
Process Validation
Stability Study
Test Method Transfer

Launch

Change Control
Customer Portal
Communicate
Manufacture

Valuable resources

QuVa has a wealth of resources and solutions to make navigating the 503B landscape easy, and help you excel in your role. Below is a selection of resources including information on new product developments and other general information that will help keep you up to date with the latest product innovations from QuVa.

BUPi and ROPi 2L Bulk Packages

Innovative Syringe Labels

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Want to know more?

For more information about how QuVa can add value to your business Ask QuVa Customer Service