Our QA team continually ensures that our Quality Systems will provide a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services that are compliant with domestic and international regulations. Our established systems guarantee traceability and compliance of all clinical and commercial products from receipt through final disposition and storage. These systems also provide feedback to ensure robust monitoring guidelines and continuous quality improvement throughout your program.
We recognize our responsibility as a contract manufacturing organization to fully comply with all contractual and current regulatory requirements. We provide regulatory support to our clients for all Chemical Manufacturing Control (CMC) sections of clinical and commercial submissions. We work strategically with clients to help with providing support documentation for regulatory filings including Investigational New Drug (IND) applications, Biologic License Applications (BLA), and New Drug Applications (NDA).
VxP Biologics has successfully completed numerous regulatory inspections, including PAI and general cGMP audits. We host several customer quality audits throughout year in addition to our internal auditing program.
Vxpbiologics.com provides development and manufacture of lyophilized products for both small and large molecule programs. We also provide services for your pre-clinical/tox studies with cGLP manufacturing of liquid and lyophilized drug product. Whether you are in early development and needing lyo cycle development and optimization, or needing full GMP manufacturing, our VxP team can help guide your project from concept to the clinic, and to market.
Some areas of specialization include:
- Low Temperature Thermal Analysis
- Product Development
- Cycle Design/Refinement
- Finished Product Testing
- Aqueous/Organic Solvents
- Pilot Plant Scale-up
Preclinical/Tox Materials (cGLP) and Clinical Manufacturing (cGMP)
- Sterile Bulk and Drug Product
- 2cc to 160cc Presentations
- 13-28mm Closures
- Temp controlled compounding/filling
- US and EU Compliant
- Cytotoxic/Highly Potent Capabilities