TEC Edmonton has enhanced its commitment to local life sciences companies with the addition of regulatory affairs and quality assurance services in support of new product development.

The regulatory affairs team has extensive experience supporting clients in various life science fields including the Medical Device, Pharmaceutical, Biotechnology and Natural Health Product industries.

These services include:

• Support of new product development including regulatory opinion research
• Project Quality Management Plans
• Pre-Meetings with regulatory authorities
• Clinical Trial Protocol review and submissions to Health Canada and/or FDA
• Site Licensing and Product Licensing/marketing applications
• ISO 13485 Certification, Quality System development and maintenance
• Compliance with FDA Code of Federal Regulations
• Auditing and assessing compliance with USA and Canadian regulations against GMP, GCP, and GLP
• Audit support for companies being audited by regulatory authorities
• Vendor selection and approval
• Software Lifecycle consulting, including validation and part 11 compliance
• Pre-Approval Inspections
• Product launch including advertising and promotion
• Complaint handling, failure investigations and Corrective Action and Preventative Action (CAPA)

The regulatory affairs team is led by John Simon, a Senior Member of the American Society for Quality and a Certified Quality Auditor through the Regulatory Affairs Professional Society.