AXSource Consulting– Providing Results-oriented Best Practices that ensure your company is on the right path

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AXSource Consulting is a leading Microsoft Partner, and provider of Microsoft Business Solutions experienced in process manufacturing, supply chain management, and distribution. The company's 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 customers and business partners. They work closely with Microsoft Consulting Services, Microsoft Dynamics Partners, ISVs, and Microsoft clients worldwide. AXSource Regulatory and Quality Consulting team provides professional services in Clinical Affairs, Regulatory Strategy and Submissions, eCTD Publishing, Quality Compliance, Pharmacovigilance, Computer System Validation (CSV), Professional Training, and Litigation Support. The firm supports a global clientele in Pharmaceuticals, Biologics, Natural Health Products, Medical Devices, Cosmetics, and Cannabis. Its proven methodology and highly experienced consultants have assisted hundreds of clients in reaching their business goals.

Significant services and solutions offered by AXSource Consulting

Regulatory Quality Business Insights: One of the company's clientele's key objectives is to assure the efficient and effective use of business funds to implement compliance measures specifically designed for their business. AXSource Consulting provides Regulatory Quality Business Insights, RQBI™. They focus on your business operations using a multi-disciplinary approach to analyze your clinical, regulatory, quality, and compliance needs from a cost-optimization point of view to enable continued and sustained value while maintaining compliance. The firm has successfully delivered hundreds of compliance solutions and service offerings to a delighted global clientele base.

Regulatory Affairs Strategy: Developing the best regulatory strategy is critical to expediting regulatory approval, off-setting any imminent risks (i.e., from competitors), and avoiding pitfalls from changing regulations during the product development lifecycle. It's easy to see how regulatory strategy encompasses a wide range of activities and disciplines. Having regulatory & clinical experts involved in the process from the beginning ensures a strategy is in place which aligns both marketing & regulatory activities.

AXSource consultants will provide you with a documented regulatory strategy that defines a path for quick approval aligned with regulatory agencies, and can be easily communicated to all stakeholders. Without a strategically planned approach, it becomes near impossible to mitigate risk. In such cases, companies will likely experience unforeseen risks, issues causing unexpected delays, increased costs, a waste of resources, and missed requirements.

Professional Training: AXSource Consulting is passionate about training and development. The firm ensures that its clients in the health products industry can maintain internal compliance and successfully host their regulatory inspections. Depending on whether your business is a small start-up or large, multi-national company, AXSource Consulting can provide you with professional training in one or more of the following areas, in a global setting.

Process Validation: Before commercialization and marketing, regulated companies have a mandate to provide sufficient evidence that their manufacturing, packaging storage, and transportation processes will consistently meet predefined quality targets and performance expectations. Only a scientifically rigorous and robust process validation methodology assures continual safety, identity, strength, purity, and quality of therapeutic products. AXSource Consulting uses a lifecycle approach to process validation that provides a well-planned, risk-based, and cost-effective approach to ensure an effective control strategy for your new or marketed products. Its approach utilizes data sets acquired throughout the process qualification activities to determine when statistically significant variability estimates and evaluation have been achieved, strengthening and reinforcing confidence that the process is highly efficient, compliant, and productive.

The driving force behind the success of AXSource Consulting

Navneet Sekhon is the Founder and also serves as the President of AXSource Consulting Inc. She is an accomplished Regulatory Affairs and Quality Assurance Executive with over 30 years of international regulatory experience. She has registered over 120,000 medical products and conducted "GxP" audits, inspections, and certification for over 300 regulated facilities globally. She started as an independent consultant in 1988 at the age of 23, assisting companies with FDA submissions and GMP implementation primarily in the biotech, pharmaceutical, and medical device industry. Her rare expertise in start-ups, experiences with a broad range of health products and success in securing many projects in regulatory affairs, quality compliance, process validation (sterile facility/utilities/process/systems), clinical affairs, trial monitoring, and even device software validation ultimately encouraged her to found AXSource Consulting Inc. in 2008.

Ms. Navneet holds an Honors Bachelor of Science in Biochemistry and Microbiology from the University of Toronto and is a certified lead auditor. She received her post-graduate training from the IVEY School of Business in Finance, Sales, and Marketing.