Alberta – Edmonton – Edmonton
Corporation
Alberta
Edmonton
Edmonton
Corporation
active
Operating name: AAA John Simon & Associates Ltd.
John Simon - Associates provides regulatory affairs and quality assurance consulting services in support of the Natural Health Product, Medical Device, Pharmaceutical, and Biotechnology industries. We provide consulting services to start-up companies to support regulatory opinion research and quality management plans. The following is a list of services provided: a. Support of new product development including regulatory opinion research
b. Project Quality Management Plans
c. Pre-Meetings with regulatory authorities
d. Clinical Trial Protocol review and submissions to Health Canada and/or FDA
e. Site Licensing and Product Licensing/marketing applications
f. ISO 13485 Certification, Quality System development and maintenance
g. Compliance with FDA Code of Federal Regulations
h. Auditing and assessing compliance with USA and Canadian regulations against GMP, GCP, and GLP
i. Audit support for companies being audited by regulatory authorities
j. Vendor selection and approval
k. Software Lifecycle consulting, including validation and part 11 compliance
l. Pre-Approval Inspections
m. Product launch including advertising and promotion
n. Complaint handling, failure investigations and Corrective Action and Preventative Action (CAPA)
Exporting: No
Primary Industry (NAICS): 541690 - Other Scientific and Technical Consulting Services
Primary Business Activity: Services
Services:
Regulatory affairs and quality assurance
Simon John
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Profile ID: LFCA-COD-O-20953