AXSource

AXSource runs two practices: implementing Microsoft Dynamics 365 business software, and advising life-science companies on regulation and quality. The two meet in its own quality compliance software, which plugs into Dynamics 365.

What AXSource offers

• Dynamics 365 implementation — ERP, Finance and Operations, customer engagement and CRM projects, plus upgrades and migrations from older Dynamics versions.
• Managed services and data — application support, Power BI and SSRS reporting, and Fabric data management.
• Regulatory affairs — strategy, eCTD publishing, Canadian market access, product labelling in SPL and XML formats, and CE marking.
• Quality compliance — inspections and audits, gap analysis, process and software validation, and GxP systems.
• Clinical and pharmacovigilance — clinical affairs support and risk management.
• Industry products — D365 add-ons including a quality and compliance solution (QCS) for Finance and Operations.

Who it works with

Its regulatory clients include makers of pharmaceuticals, biologics, active ingredients, medical devices, cosmetics, natural health products and cannabis. The Dynamics practice also serves food and beverage, hospitality and healthcare businesses.

Key facts

• Partnership: Microsoft Dynamics 365 Partner
• Leadership: its founder, Navneet, holds a US patent for the QCS software
• Regulators covered: EU, FDA and Health Canada