Pauline McGregor, Ph.D., CChem MRSC, founded PMcG Consulting in 2006. With over thirty-five years in the pharmaceutical industry and a PhD in chemistry, she moved from Edinburgh to Canada in 1995 to complete her postdoctoral research at the University of Western Ontario. She is a member of the Royal Society of Chemistry and is listed on its Directory of Consultants. Pauline was a member of the original USP expert panel for Validation, Verification and Transfer of Analytical Procedures and has served on a USP Chemical Medicines expert committee.

Pauline is an expert in analytical chemistry, quality systems and procedures and global GMP regulations. She is highly regarded as a trainer in her specialised fields, an insightful consultant, and an auditor known for her diligence.

Pauline brings extensive technical expertise, supporting laboratories and manufacturing teams in the development, transfer, verification, validation and continual improvement of analytical procedures and processes. She enhances operational efficiency and resolves troubleshooting challenges within both developmental and routine environments through her validation programs, investigations of OOS results, evaluation of changes/improvements to the process, assess the impact of these on the product/patient and propose and execute necessary revalidation criteria. Her core interest is in analytical Quality by Design (QbD) and the application of advanced methodologies in analytical procedures to achieve reliable and consistent performance across their lifecycle. Since 2010, she has been an active contributor and advocate in the advancement of this field.

 

Pauline is also skilled in designing and implementing quality systems so that new manufacturing and testing firms can comply with GMP regulations. She also has expertise in evaluating and upgrading existing quality systems to enhance operational efficiency.

She has applied her expertise internationally across the UK, Europe, Canada, the US, Jordan, Brazil, and China, assisting companies in preparing for GMP inspections to obtain European, Health Canada, or FDA GMP licenses.

 

Pauline recognized the gaps in communication and documentation among academia and industry, especially between universities and the needs of employers. She also observed the importance of clear communication within pharmaceutical sectors—Manufacturing, Quality Control, R&D, and Quality Assurance—to achieve shared goals efficiently. PMcG Consulting was founded to address these issues by providing training, consulting, document review, and auditing services.