Quality Assurance and Regulatory Support

///Quality Assurance and Regulatory Support
Quality Assurance and Regulatory Support2018-01-03T02:19:15+00:00

Quality Assurance

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 Biologics program.

Regulatory Support

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.

 

Contact us today for a free consultation about your Biologics program today.