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.
2020 was the year in which we experienced disruptive change at a pace and a scale that we could never have imagined. Yet it was also the year in which many retailers embraced digital like never before. Take REI for example, which launched a new virtual outfitting service to help customers assemble bikes, find theMarch 31, 2021
Digital commerce is reshaping every step in the supply chain. Consumers today expect seamless omnichannel buying and after-purchase experiences with multiple fast delivery options. Many organizations, however, are struggling to modernize operations to keep up with the growth. In fact, a recent study* found that nearly 61 percent1 of companies expect over half of theirMarch 31, 2021
Health Canada is adapting its systems with advances in science to maximize the safety of Canadians, and one of their initiatives is to improve drug product labels. The Agency recognizes that the publicly available labelling information should be transitioned from unstructured formats, like Portable Document Format (PDF), to an advanced format called Extensible Markup LanguageMarch 30, 2021
After several reports on European countries suspending the use of the AstraZeneca COVID-19 vaccine, many Canadians are wondering if it is safe to use. What you should know Law – Manufacturers in the pharmaceutical industry are required by law to report Adverse Drug Reactions (ADRs) to regulatory agencies such as Health Canada. ADRs are harmfulMarch 19, 2021