AXSource Consulting supports global manufacturers, distributors, suppliers, CROs, laboratories, packagers and labelers of vitamins, minerals, essential fatty acids, amino acids, probiotics, herbal products, homeopathic medicines and non-prescription drugs in their successful navigation through applicable regulatory and quality processes by providing cost-effective and compliant solutions to facilitate product launches globally.
Our customers range from large, multi-national companies to small business entities, often virtually run.
Our Regulatory & Quality Services include
- Regulatory Strategy & Gap Analysis
- Liaison with Regulatory Authorities
- Natural Health Product Master File (NHP-MF) Support
- Clinical Trial Applications
- Regulatory Market Approval & Post Market Filings (e.g. Product License Applications – PLA, NDA – 505(b)(1) & 505(b)(2), ANDA, Time & Extent Applications – TEA, Traditional Herbal Medicinal Products Registration, License Amendments, Notifications, Fundamental Changes)
- Site License Applications (SLA), Renewals Amendments, Notifications
- International Trade Certificates (ITC) for NHPs & GMP compliance
- Quality Assurance Report (QAR) preparation
- Quality Management System (SOPs & Control Records), Implementation & Training
- Validation (Analytical Method, Process, Equipment, Software & Computer Systems)
- Audit Support (Regulatory Agency Inspection Hosting, Supplier Certification, Self-Inspections for compliance to GxPs (i.e. GLP, GMP, GCP, GDP & GVP))