Quality Systems

Pharmalliance Consulting Ltd partnered with a leading U.S.-based mRNA manufacturer to establish a robust Quality Management System (QMS) for their cutting-edge facility.

This high-impact project aimed to ensure regulatory compliance and operational excellence in the rapidly advancing mRNA therapeutics sector.

The scope of work included:

• Supplier Quality Management Program Development: Drafting critical procedures, including supplier qualification, audit processes, quality agreements, and deviation management, tailored to industry standards.

• Policy and Procedure Design: Creating foundational documents such as the Quality Policy and Data Integrity Policy to establish a strong compliance framework.

• Collaborative Execution Strategy: Engaging stakeholders through structured kickoff meetings, iterative review cycles, and alignment with the client's QMS platform for seamless integration.

Regulatory and operational risks required meticulous planning and expert execution. 

Pharmalliance delivered comprehensive solutions, ensuring the QMS met stringent FDA and EU regulatory standards, empowering the client to lead in the innovative mRNA domain​.

Are you ready to elevate your quality systems? 

Contact us today to ensure your compliance and innovation success.