NHPs & OTC DRUGS

Microsoft Dynamics ERP For Quality and Compliance

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))