Advanced Therapeutic Medical Products (ATMP) require specific regulatory and Good Manufacturing Practices requirements (ref. Eudralex volume 4, Part IV).

Using our know-how and expertise, at PMSystem we offer a complete package to support you in successfully dealing with all quality and regulatory aspects related to ATMP.

Our strategy based on risk approach takes in consideration the quality risks aspects associated with ATMP:

  • The biological characteristics and origin of the cells
  • The biological characteristics of the vectors
  • The level and characteristics of the expressed protein (for gene therapy products)
  • The properties of other non-cellular components (raw materials, matrixes)
  • And the manufacturing process.

Services offered

  • Support for quality and regulatory aspects
  • Support in the construction and upgrade of the manufacturing facility
    - Conceptual Design
    - Clean room qualification from URS (User Requirements Specifications) up to Performance Qualification (URS-DQ-IQ-OQ-PQ)
  • Representative functions such as contracted Qualified Person or Quality Manager
  • Risk assessments
  • Mock audit and third-party audit
  • System qualification
  • Training