What We Do
Regulatory & Quality Consulting
Our AXSource Regulatory & Quality Consulting team provides professional services in Clinical Affairs, Regulatory Strategy & Submissions, eCTD Publishing, Quality Compliance, Pharmacovigilance, Computer System Validation (CSV), Professional Training and Litigation Support. We support a global clientele base (including start-ups and Big Pharma) in Pharmaceuticals, Biologics, Natural Health Products, Medical Devices, Cosmetics and Cannabis. Our proven methodology and highly experienced consultants have assisted hundreds of clients in reaching their business goals.
Our AXSource IT Advisory Services team is a leading Microsoft Partner and provider of Microsoft Business Solutions experienced in process manufacturing, supply chain management, and distribution. Our IT Advisory team is exclusively focused on offering ERP products and services for Microsoft Dynamics AX, Dynamics 365 Operations and has a record of managing and implementing complex business solutions for our customers and business partners. We work closely with Microsoft Consulting Services, Microsoft Dynamics Partners, ISVs and Microsoft clients all over the world.
Charlotte has an incredible breadth of experience in quality assurance and quality compliance. Since 2013, Charlotte has been a Senior Consultant and an integral part of the AXSource family. With over 20 years in QA Management, she has hosted and coordinated hundreds of successful inspections with regulatory agencies (drug product, controlled substances, and medical devices)April 28, 2022
This year’s theme for International Women’s Day (IWD) is #BreakTheBias. There is a detailed report on Women in the Workplace that LeanIn.Org and McKinsey & Company issues each year. It’s based on research from 423 companies in the United States & Canada. Participants are from the private, public, and social sectors. And over 65,000 employeesMarch 8, 2022
To maintain an active Medical Device Establishment Licence (MDEL) must apply to renew their licence before April 1 each year. The purpose of the Annual Licence Review (ALR) process is to ensure that MDEL holders continue to comply with the Canadian Medical Device Regulations, and to ensure licence information is current with Health Canada. TheDecember 22, 2021
Health Canada, the US Food & Drug Administration, and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) have collaborated to identify 10 guiding principles to govern the development of Good Machine Learning Practice (GMLP). Medical devices that use artificial intelligence (AI) and machine learning (ML) technologies are increasingly recognized for their potential impact onNovember 4, 2021