Projects Delivered

US market release of Cosmetics

Regulatory Affairs & Quality Control consulting services, GVP Audit & Outsourced Quality & Compliance Services (QA Release for Pharmaceuticals)

Regulatory Submissions (eCTD), Quality & Compliance (DEL) for Start-up MAH

GMP Training, DEL Application, QMS development, and Validation Studies for Drug Wholesaler

Strategic Advice Global Medical Device Manufacturer for Regulatory Affairs Outsourcing (medical imaging products) and facility licensing in accordance with Health Canada requirements

Regulatory services for advice and EU design dossier preparation for CE Marking

Regulatory/Compliance Support post Health Canada Inspection

SAP R/3 Computer System Validation

Determine suitability of its established manufacturing, Quality Management System (QMS) and quality control activities

Regulatory Services to obtain Device Registration with Health Canada

eCTD Publishing

Regulatory Services to submit eCTD with FDA

Registration of medical device with FDA and RAQA maintenance activities to remain in compliance

Professional Training

Good Laboratory Practices/ Pre-Clinical Training

QMS Development for a Cannabis Retailer

Determine Quality & compliance gaps to Health Canada& business requirements of its distributor

Preparation of EU Technical File for Combination drug-device product and drug component

Development of QMSfor Start-up, US FDA 510K Application

GMP auditing of Pharmaceutical Quality Management System

Active Pharmaceutical Ingredient(s)

Establishment License approved by HC in order to import and offer APIs in Canada

Pharmaceutical GMP & PV System effectiveness & Audit

Physican let Market Access Application with Ontario Ministry for Rare Disease in Children

Regulatory services to submit eCTD for vaccine to Bureau of Biologics, Health Canada

Quality and compliance gaps and amend/devise required compliance procedures in order to conform to Health Canada & business requirements

Software & Computer System Validation

Computer System Validation

QMS & Regulatory Services for Start-up to DEL Approval. ERP Configuration with Cloud Hosting

EDC Software System Validation& Foreign Laboratory GCP Certification

Conduct a regulatory due diligence exercise for a cardiac device under development

Sterile Manufacturing Facility GMP assessment

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)

CE Marking Services

Regulatory/Quality services

Remediation following Clinical Trial Suspension (Bi-lingual Support)

Regulatory / Compliance Services for Device Licensing

Develop GMP for Start-up, export compliance, QMS Development to Health Canada requirements, preparation and hosting for Health Canada inspection and final DEL certification

Developed GMP for Start-up through to regulatory certification