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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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