Urmi Quality Management Consulting Pty Ltd

About Urmi Quality Management Consulting Pty Ltd

At Urmi Quality Management Consulting (UQMC), we combine the best quality system tools from both the pharmaceutical and ISO 9001 quality management systems to help life science organisations establish compliant and phase appropriate quality systems that adapt to the changing needs of the business.

Our aim to help companies understand the concept of quality, simplify business and operational processes and create a culture that is engaging, lean, efficient while maintaining regulatory compliance.

We off the following services in the areas of pharmaceutical/life science manufacturing; Translational & Drug Development; and Training & coaching:

- Design and implementation of phase-appropriate quality management strategy

- Gap analysis of existing quality systems against regulatory requirements and industry best practices

- Continuous improvement planning and execution

- Support and assistance with implementation of various QMS elements including electronic quality management

systems

- Support with generation and review of quality related documentation and quality oversight (person-in-place)

- Technology transfer support

- Auditing services - Vendor, Contract manufacturing partners and service providers

- Due Diligence for Quality Systems

- Customized training on GMP and QMS elements (Deviations, CAPA, Change Management, Quality Risk Assessments,

Data Integrity etc.)

- Staff coaching on the concepts and practical application of quality principles