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.

QuVa's Medical Staff Using Advanced Printing Machines for Labeling Products

Our products like R.E.C.K, Buffered Lidocaine with Epinephrine, Dexmedetomidine, Dexamethasone, and Potassium Chloride with Lidocaine, were developed for customers to meet their clinical needs, while our unique 2L Pharmacy Bulk Package for Bupivacaine and Ropivacaine help pharmacies deliver these medications into end-use containers, like pain pumps, more efficiently.

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 these 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

QuVa's Process Steps Connector Line to Right
Development

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

QuVa's Process Steps Connector Line to Right
Launch

Change Control
Customer Portal
Communicate
Manufacture

QuVa's Process Steps Connector Line to Left
Formulate

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

QuVa's Process Steps Connector Line to Left
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.

Cefazolin with extended BUD (Now 60 Days)

Dexmedetomidine

CADD Midazolam

Dexamethasone

Kit CheckTM

Morphine PCA 

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