Northwest Pharma Consulting Inc. (NPCI) was founded in 2006 by Tony Shaw, Ph.D., after more than 14 years working in preclinical and clinical drug development. During that period, he gained extensive experience of all CMC aspects of drug development and associated activities necessary to support phase I, II and III clinical trials for new chemical entities. This knowledge was gained from an Analytical Development and Quality Control perspective, but required a thorough understanding of not only the full array of modern analytical techniques for drug substance and drug product characterization and quality control, but also drug substance chemical process development and scale up, and dosage form selection, development and clinical trial material manufacture.

From hands-on laboratory to senior management responsibilities, Tony has developed a strong understanding of early phase drug development, effective project and people management skills, GLP and GMP compliance of preclinical bioanalytical testing and active pharmaceutical ingredient and drug product manufacture in US, Canadian and EU regulatory environments.

Early phase clinical drug development, especially for small, primarily research-based biotech and pharma companies, is an exciting but high-risk business. Once a promising new drug candidate has been identified, the next step is to bring this potential new therapy into clinical trials as quickly and as cost-effectively as possible. As the sponsor, you have ultimate responsibility for ensuring that the studies submitted are reliable and that clinical trial materials are manufactured and tested in compliance with current Good Manufacturing Practices. To meet these obligations requires multidisciplinary expertise to plan, monitor and coordinate the myriad of interconnected CMC activities.

For most biotech companies, big and small, the need to outsource certain research activities is a business reality. The choice of Contract Research/Manufacturing Organizations is huge, some are good, others not so good. Given the cost of development studies, it is essential that they be performed in such a way that the results are reliable and submittable to regulatory agencies. The cost in lost time for a repeated study goes far beyond the direct disbursement costs. It is therefore vital that a sponsor develops a positive relationship with contractors, and holds them accountable in terms of quality and timing of deliverables.

With years of experience in managing contractors and a thorough understanding of GLP/GMP and regulatory requirements, our hands-on support represents an essential insurance policy against wasted time and money. NPCI represents one-stop shopping for client support in the areas of CMC development and bioanalytical testing. The scope of services can range from simple protocol and data review, to complete CMC/bioanalytical project management support. Based on the West Coast of Canada, we seek to serve clients across North America. Consulting services can be provided in both official languages of Canada.