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Regulatory Affairs
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Preparation
of product submissions & license applications for EU,
FDA, CNSC & Health Canada approval (Pharmaceutical,
Medical Devices, & Bio-pharmaceutical/Biologics)
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Mandatory Product Change
Notices & Significant Change Reporting for Medical
Devices
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Investigational Testing
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Government
Liaison (Review Meetings, Industry Trade Support,
Issue Management)
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Facility
Approvals & Licenses
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Label
Approval & Promotional Literature Review
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Annual
Registration Activities
Compliance
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Specialize
in customizing “GXP” processes (i.e. GMP, GLP, GCP)
for start-ups
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Regulatory
inspections preparation & support
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ISO Quality
System Standard (ISO 13485, ISO 9001, ISO 14000, ISO
18001 etc.)
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Liaise with
Certification assessment organizations
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Risk
Management
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Vendor
Compliance Systems
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Pharmacovigiliance
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Regulatory
Reporting (Mandatory Reports, Adverse Event Reporting)
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Recall
Management
Validation
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Master
Validation Plans & Protocols (IQ, OQ & PQ)
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Process
Validation
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Analytical
Methods Validation
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Computer
System Validation
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Project
Management Services with External Engineering or
Software Consulting firms
ISO Certification
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Quality
Management System Review - Gap Analysis
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QMS Consulting &
Implementation
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Selection of
Registrars
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Coordination
of Quality System Audits
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Registration
with Health Canada (ISO 13485 for Medical Devices
Approval)
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Surveillance
Audit Support
Business Process Re-engineering
Privacy Compliance
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Privacy
Compliance processes – PIPEDA & Provincial bills
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Liaise with
Canada’s Privacy Experts
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Gap Analysis
& Business Risk
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Training
Programs
Environment,
Health & Safety (EH&S)
Performance / Personnel Management
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Recruitment
support
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In-house
Training (Regulatory, Compliance, Technical, Process,
etc.)
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External
Training Coordination
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Executive
Coaching
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Program Management
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