A well designed, tailored, and implemented Quality Management System (QMS) empowers organizations to progress efficiently at every phase of the product lifecycle from R&D to Clinical and Commercial operations.

At Pharmatek Solutions, our experienced team of Subject Matter Experts have built QMS’ from the ground up and performed gap Assessments to identify nonconformities with relevant regulations.

Whether you need to build a new QMS, improve an existing one, or develop a phase appropriate QMS; our experts work closely with you to stay compliant with current regulations, standards, and guidelines.

Our range of Quality Management System services include:

• GAP Assessment of the QMS, e.g., against 21 CFR 211, EU GMP and ICH Q10
• Medical Device quality management, following ISO13485 and 21 CFR 820
• SOPs Management
• Quality Risk Management
• Change Management
• Deviation management
• Learning Management
• Supplier management
• Implementation of eQMS solutions
• Set up and implementation of CRO, CMO Onboarding processes