AXSource Consulting supports global drug manufacturers, distributors, wholesalers, suppliers, CROs, laboratories, universities, packagers, labelers and related industry clients in their successful navigation through complex regulatory and quality processes by providing effective & compliant solutions to facilitate product launches in global markets.
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 (Pre-submission meetings, Dispute Resolution / Market Access Refusals, Waivers / requests)
- Premarket Clinical Trial Applications (e.g. CTA, Traditional & Exploratory IND)
- Drug Master File (DMF) support for active ingredient (API) manufacturers
- Market Authorization Applications for New Drugs, Generics, Biologics (e.g. NDS, NDA 505(b)(1) & 505(b)(2), MAA, ANDS, ANDA, BLA, DIN)
- Post-Market Filings (e.g. SNDS, PAS, Annual Notifications / Reports, Post DIN changes, NC, Type IA / IB / II Variations, Extension Applications, NOD / NON responses)
- Drug Establishment Licensing (DEL), Facility Registration & Listing, Amendments, Annual Reviews & Updates
- Customized Quality Management System (SOPs), Implementation & Training
- Validation (Analytical Methods, Process, Equipment, Utilities (e.g. WFI, DI system, clean room technology, HVAC, CIP/SIP, compressed air etc ), Software & Computer Systems (e.g. LIMS, LIS, ERP, FDA 21 CFR Part 11)
- Expert Audit Support (Agency Inspections, Supplier Certifications, Self-Inspections for compliance to good laboratory practices, good clinical practices, good manufacturing practices and good pharmacovigilance practices – GLP, GCP, GMP, GDP, GVP)