Pharmaceuticals

AXSource Consulting supports global manufacturers, distributors, suppliers, CROs, laboratories, universities, packagers, and labellers of medical devices 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. We augment our Regulatory & Quality Services with automated software solutions.

Regulatory & Quality Services

Pharma Medical Devices
  • 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)

 

  • Regulatory Strategy
  • Gap Analysis
  • Liaison with Regulatory Authorities (pre-submission meetings, refusals or product holds)
  • Investigational Testing, Clinical Trials (e.g. ITA, IDE)
  • Market Access (e.g. Class II, III, IV device applications, STED, premarket notification-510(k), premarket approval-PMA, PDP, HDE, Technical File, Conformity Assessment, Declaration of Conformity, CE Marking)
  • Transitioning from CMDCAS ISO 13485 to MDSAP; certification consulting to MDSAP
  • Post-Market Regulatory services (e.g. License Renewals, Amendments, PMA Supplements)
  • Medical Device Establishment Licensing (MDEL), Facility Registrations
  • Custom Quality Management System (QMS), SOP Development, Implementation & Training
  • Advice on Recognized Medical Device Standards
  • Validation of Software for Medical Devices
  • Validation of Software in regulated Manufacturing Processes
  • Audit Support (Internal, Supplier Certification, Self-Inspections for compliance to GxPs (i.e. GLP, GMP, GCP, GDP & GVP))
  • Regulatory Agency Inspection preparation, co-hosting and closure
  • Expert opinions & support in litigations/ class action lawsuits

 

At AXSource, we understand that Pharma companies not only need compliance software, but also an Enterprise Resource Planning system to manage operations. As a result, we created D365 QCS™, a Quality and Compliance Solution built for Microsoft Dynamics 365 ERP. It enhances Dynamics 365 by adding design elements essential for Life Sciences companies.

Unlike standard solutions developed by IT experts to meet industry requirements, D365 QCS™ is designed and developed  under the guidance of AXSource’s regulatory and compliance experts  who have prior Good Production Practices implementation, auditing, and validation expertise. Our software offers significant cost savings for our clients by providing a validated solution out-of-the-box and eliminating the need for an on-site validation effort. D365 QCS™ is the complete solution for quality and compliance.