Quality Services
Our team of qualified, trained and experienced quality management professionals provide you with quality compliance services that include establishment and on-going management of;

Drug GMP services for Distribution, Importation and Manufacturing Facilities. This includes but not limited to;

  • Establishing new InGMP facility
  • Preparation for & Representation at NAFDAC, Health Canada & US FDA Audit
  • Vendor Auditing & Periodic Self-Inspection
  • QA Product release services
  • Validation & Stability studies  services
  • API GMP compliance services
  • Creation & revision of SOP
  • GMP & SOP Training

Natural Health Products GMP services for Importation and Manufacturing Facilities This includes but not limited to;

  • Establishing new NHP GMP compliant quality system for manufacturing & importation facilities
  • Execution and completion of Quality Assurance Report (QAR) for Local & Foreign facilities
  • Off-site on-going QA unit & Product release services
  • Creation & revision of SOP
  • GMP & SOP Training

Medical Device QMS (ISO 13485, CMDCAS ISO 13485 & MDSAP) for Virtual Manufacturers and Fabricators;

  • Establishing (New) & Daily Off-Site Management
  • Surveillance/Certification Audit Preparation & Representation
  • Vendor Auditing
  • Canadian MDEL & FDA 21 CFR 820 Regulatory Audit Preparation & Representation
  • Implant Registration Record Maintenance
  • QMS & SOP Training

Complete Product Vigilance Services (Pre-& Post Approval Vigilance for Drugs, Devices & LRVHP);

  • Complaint receiving and product information Contact Center services
  • Setting-up a new or updating existing PV?
  • Preparation of SOPs and related records required for effective PV management
  • Literature Search, Signal detection Medical Reviews & Annual Summary reports preparation
  • PV System Personnel training for effective system management
  • 2nd Party audit; performance of periodic PV Self-inspection
  • Medical Device Mandatory Problem Reporting Management
  • Post-Market Surveillance Program for LRVHP; Adverse Event recording and Incident/Annual Reporting

Feel free to contact us with your request for review and quote.
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