Services Offered

In today's pharmaceutical industry there is a definite need to understand technical and quality issues regarding daily operations, science and regulatory requirements. 

PMcG Consulting offers Technical and Quality support to:
  • Laboratories
  • Manufacturing sites
  • Distributors
  • Companies who require additional technical understanding during regulatory audits
To assist with technical problem-solving relating to:
  • Analytical Procedures (QbD Lifecycle approach, Development, validation, Verification and Transfer)
  • OOS Investigations
  • Stability studies
  • Cleaning validation.
  • Facility Validation
  • Manufacturing Process Validation
  • Analytical Method development and validation
To assist with opportunities for improvement within the Quality Management System:
  • Root cause investigations
  • Corrective and Preventative Actions
  • Trending of Quality System Incidents for continual improvement
  • Self-Inspection program
  • Training Programs
  • Master validation plans
  • Data Integrity considerations
  • Quality Management Systems
  • Quality System Elements
  • Compliance with Good Manufacturing Regulations

Technical support is also offered to help prepare for and participate in Regulatory audits.

If you would like to discuss how we can provide technical support or require further information, please: Contact Us

Recommendations

  • Pauline is keen and hardworking, she loves her sciences and passionate about what she does. I so much enjoyed working with her, she has provided great insight on many technical and scientific issues related to analytical method development and analytical method validation. Her most important quality is her patience and perseverance and of course, fun to work with
  • Contracted Pauline to assess analytical methods validation, and to subsequently create a 'gap' report - and then to work at 'fixing' the gap. Pauline was excellent in her attention to detail, and her thorough knowledge of what was needed. She also worked on several projects after that one - always with the same high standards and commitment to provide value to the client. I heartily endorse her work.
  • Pauline is an excellent professional in the life science business. She did a great job as project manager in analytical development and validation at SGS Life Science Services. She was appreciated by her colleagues and her customers.
  • Pauline's ability to understand and integrate the scientific challenges of industry, with government and academia are unsurpassed. I am so confident with her ability to deliver meaningful yet pragmatic leadership as it applies to the pharmaceutical industry that I have recommended her to numerous prominent companies who have subsequently hired her and been extremely happy with the results she is able to deliver.