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Services

Manufacturing Oversight

Past clients and Knowledge base

Manufacturing Oversight

Manufacturing oversight on SOW, RFPs, Manufacturing compliance for therapeutics projects. Cross-functional work with the PMO, Pre-Clinical Services, Analytical services, Manufacturing, Facilities, QC/QA to provide oversight including but not restricted toGMP gap analysis for the production process,  Support clinical-phase-appropriate internal GLP/GMP Quality System.

Quality Compliance

Past clients and Knowledge base

Manufacturing Oversight

 QA, Manufacturing Operational and Quality Operations Management oversight- Deviation management and approvals, QC, Manufacturing processes,BPR/Disposition, QMS, QC, QA, Change Controls and investigations.  QMS compliance with Trackwise, Master Control, Blue Mountain, SharePoint documentation and compliance. 

Past clients and Knowledge base

Past clients and Knowledge base

Past clients and Knowledge base

 Catalent Biologics, Biotheraputics Manufacturing Centre,  Centre for Commercialization of Regenerative Medicine,   Centre for Probe Development and Commercialization  CSIR National Chemical Laboratory, Human Health Therapeutics Research Centre, MRC National Institute for Medical Research, Ontario Bioscience Innovation Organization, Ontar

 Catalent Biologics, Biotheraputics Manufacturing Centre,  Centre for Commercialization of Regenerative Medicine,   Centre for Probe Development and Commercialization  CSIR National Chemical Laboratory, Human Health Therapeutics Research Centre, MRC National Institute for Medical Research, Ontario Bioscience Innovation Organization, Ontario Cancer Institute, Resilience Biotechnologies Inc, Sanofi Pasteur and Virocule Inc.  

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