Baker’s relationship with QuVa Pharma started originally with a project in its Sugar Land, TX facility. Then, in 2017, that relationship grew as QuVa was expanding with a new, purpose-built facility in Bloomsbury, NJ with all new laboratory space and clean rooms. Baker provided all the primary engineering controls to provide ISO 5 air cleanliness for compounded sterile products in clean rooms and biosafety cabinets for quality labs in the New Jersey facility.
QuVa now has over 300,000 sq ft of sterile manufacturing space between its Texas and New Jersey facilities. “Baker was pleased to partner with QuVa to support them in providing the highest quality sterile products for patient care and delivering on their cGMP standards”, stated Cybelle Guerrero, Baker’s Director of Sales.
Mike Rutkowski, Vice President of QuVa’s Technical Operations adds: “The 503B Industry is a tremendously dynamic and ever evolving environment. Therefore we required partnership with suppliers who have that understanding and can match their skills with our needs. Without it, our mission can’t be accomplished and competitive advantage would be lost. Baker has proven to not only be reliable, but to share creative solutions through technical exchange that leads directly to compliant application. It is because of that capability that we will continue to build on our partnership with a common goal of using innovation for the advancement of high-quality products that support patient care. “
QuVa is on the forefront of changing 503B outsourcing for the better and helping translate FDA’s regulations into processes that work and can be done at scale.
To learn more about QuVA: www.quvapharma.com