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.
Health Canada has introduced a new questionnaire to track the inclusion of disaggregated data on sex, age, and race, in clinical trials. What is disaggregated data? Disaggregated data is the presentation of data broken into segments. For example, test results for marginalized groups versus the entire test population (i.e., the aggregate). Health Canada uses disaggregatedOctober 5, 2022
Leading Canadian Menswear brand SAXX chooses AXSource as its partner to implement Microsoft Dynamics 365 as its new ERP platform
OAKVILLE, Ontario July 19, 2022 – AXSource has been selected by SAXX, a leading Canadian menswear brand, to integrate Microsoft Dynamics 365as its next-generation business software platform. SAXX will migrate to Dynamics 365 to gain access to an end-to-end business management and business intelligence platform that will help the company improve its supply chain, budgeting,July 19, 2022
Pharmacovigilance, commonly known as drug safety, is the process of collecting, detecting, assessing, monitoring, and preventing adverse events (AEs) associated with the use of medicinal products. Pharmacovigilance risk management involves many different activities, such as case intake and processing, causality assessment, narrative writing, regulatory submission of Individual Case Safety Reports (ICSRs), aggregate reports, signal detectionJuly 7, 2022
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