Proven regulatory, operational and technical consulting services & training solutions in the pharmaceutical, biotech and allied industries. 


The Tungsten Shield Group provides comprehensive consulting and training services to the pharmaceutical, biotechnology, medical devices and allied industries. Tungsten Shield Group expert consultants are prominent leaders in their respective fields and have decades of collective managerial GxP experience in the pharmaceutical, biotech and medical devices industries acquired through working with large multinationals, regulatory agencies, and academic organizations. The Tungsten Shield Group has wide-ranging experience, from the setting up of Quality Systems, to taking our clients through to commercial production successfully.

Tungsten Shield Group provides innovative solutions assisting companies and organizations in meeting and surpassing federal regulations, including full plant GMP audits and assessment, expert propositions in creating successful road maps to quality, and meeting with FDA, Health Canada, EU and other international regulatory expectations. Our expert team of US and international specialists work with manufacturers to ensure quality, compliance, risks prevention, and to provide strategic, focused, and optimum solutions.


• Pharmaceutical Microbiology
• Environmental monitoring
• USP microbiology
• Sterility assurance
• QC compliance for the production of Phase 1, 2, 3 and commercial products from bacteria, yeast and mammalian cells
• Validation and requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials
• Aseptic processing
• Cleaning Validation
• Rapid microbiological methods
• Regulatory compliance
• FDA regulatory requirements
• Health Canada regulatory requirements
• ICH guidelines
• EU & other International regulatory requirements
• Raw materials risk management and testing
• Laboratory controls
• Method validation
• Calibration
• Reference standards
• Quality management
• Annual quality review
• Investigations
• Analytical chemistry
• Analytical development
• Project management
• Strategic drug development
• Stability sciences
• CMC submission
• OOS/OOT investigations
• QA compliance
• Validation
• cGMP Quality
• Drug supply chain: logistics, process, manufacturing, outsourcing
• GMP Quality: QMS, assessments, audits, remediation
• Clinical Development: audits, assessments and planning
• Regulatory Affairs: submissions, inspections, recall
• Corporate Compliance: governance, risk and strategy
• Preparation for regulatory inspections

Tungsten Shield Group also plans and delivers the industry's highest quality regulatory compliance and operational live online training programs (Live Training Webinars) through Pharma Webinars. Developed and delivered following e-learning best practices, Pharma Webinars live training programs are interactive, instructor-led live training solutions that effectively provide the most up to date regulatory, operational and technical information to organizations and professionals in the industry.

Pharma Webinars - A division of the Tungsten Shield Group is a trusted name in the development and delivery of specialized training programs on-site or on-line which are customized to meet client specific training requirements in the pharmaceutical, biotechnology and allied industries.