Quality & Compliance

Cellipont’s Quality Unit includes our Quality Assurance, Quality Control, and Validation groups.

We utilize a Quality Management Systems (QMS) developed to ensure high quality standards that are focused on meeting regulatory requirements and the delivery of safe, pure and quality products to our clients and to the patient.  Our QMS reflects a phased-cGMP approach from development to commercial product life-cycle allowing flexibility and rigidity as needed.

We take pride in understanding our client’s program needs early on through collaboration and partnership.

Quality Assurance oversees and facilitates:

  • Establishment Quality Agreements
  • Disposition of GMP product to the client, including the disposition package
  • Establishment and approval of Client-specific cGMP documentation
  • Client Audits
  • Supplier Qualification
  • Quality Risk Management
  • Regulatory Inspection support

Validation Support Services include:

  • Client processes and products
  • Equipment IOQ and PQ, as applicable
  • Facility and Utility qualification
  • Aseptic Process Validation and Simulation
cell therapy scientist in lab

How can Cellipont help?

Please send us a note and we’ll get right back to you!