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