Projects Delivered

Array
Canada
Health Canada Regulatory Inspection – Corrective Action Response
Array
Cosmetics
US market release of Cosmetics
Array
Canada
Regulatory Affairs & Quality Control consulting services, GVP Audit & Outsourced Quality & Compliance Services (QA Release for Pharmaceuticals)
Array
Biologics
Regulatory Submissions (eCTD), Quality & Compliance (DEL) for Start-up MAH
Array
Canada
GMP Training, DEL Application, QMS development, and Validation Studies for Drug Wholesaler
Array
Canada
Strategic Advice Global Medical Device Manufacturer for Regulatory Affairs Outsourcing (medical imaging products) and facility licensing in accordance with Health Canada requirements
Array
CE Marking
Regulatory services for advice and EU design dossier preparation for CE Marking
Array
Canada
Regulatory/Compliance Support post Health Canada Inspection
Array
Canada
SAP R/3 Computer System Validation
Array
Canada
Determine suitability of its established manufacturing, Quality Management System (QMS) and quality control activities
Array
Canada
Regulatory Services to obtain Device Registration with Health Canada
Array
eCTD Publishing
Regulatory Services to submit eCTD with FDA
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Medical Device
Registration of medical device with FDA and RAQA maintenance activities to remain in compliance
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Professional Training
Good Laboratory Practices/ Pre-Clinical Training
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Canada
QMS Development for a Cannabis Retailer
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Canada
Determine Quality & compliance gaps to Health Canada & business requirements of its distributor
Array
Europe EU
Preparation of EU Technical File for Combination drug-device product and drug component
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Canada
Development of QMSfor Start-up, US FDA 510K Application
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Canada
GMP auditing of Pharmaceutical Quality Management System
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Active Pharmaceutical Ingredient(s)
Establishment License approved by HC in order to import and offer APIs in Canada
Array
Canada
Pharmaceutical GMP & PV System effectiveness & Audit
Array
Canada
Physician let Market Access Application with Ontario Ministry for Rare Disease in Children
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Biologics
Regulatory services to submit eCTD for vaccine to Bureau of Biologics, Health Canada
Array
Canada
Quality and compliance gaps and amend/devise required compliance procedures in order to conform to Health Canada & business requirements
Array
Software & Computer System Validation
Computer System Validation
Array
Canada
QMS & Regulatory Services for Start-up to DEL Approval. ERP Configuration with Cloud Hosting
Array
GxP System
EDC Software System Validation& Foreign Laboratory GCP Certification
Array
Canada
Conduct a regulatory due diligence exercise for a cardiac device under development
Array
Canada
Sterile Manufacturing Facility GMP assessment
Array
Canada
Gap Assessment per FDA & Health Canada Compliance of a Manufacturer in China, establish and deliver custom GMP Training, Computer Systems Validation (ERP, Process Control, LIMS, Formula Management)
Array
Europe EU
CE Marking Services
Array
Canada
Regulatory/Quality services
Array
Canada
Remediation following Clinical Trial Suspension (Bi-lingual Support)
Array
Canada
Regulatory / Compliance Services for Device Licensing
Array
Canada
Develop GMP for Start-up, export compliance, QMS Development to Health Canada requirements, preparation and hosting for Health Canada inspection and final DEL certification
Array
Canada
Developed GMP for Start-up through to regulatory certification