AXSource Consulting Inc. – Empowering Businesses through Comprehensive Regulatory and Clinical Expertise

AxSource Consulting Inc. is a leading provider of comprehensive global business solutions in the fields of clinical, regulatory affairs, compliance, and quality assurance/control across various industries, including pharmaceuticals, biologics, cosmetics, natural health products, medical devices, healthcare, information technology, and allied sectors. The company specializes in offering governmental liaison services, establishing start-up operations, and supporting clients through new product launches.

Distinguished by its team of industry experts, AxSource Consulting Inc. initiates its consulting services with a thorough analysis of each client's unique business situation. This involves identifying and mitigating potential business risks while creating a meticulously crafted, cost-optimized project plan. Clients opting for AxSource Consulting's consulting services can rest assured that they have access to top-notch expertise, enabling them to achieve significant milestones in their sales and marketing strategy.

For those selecting AxSource Consulting's professional regulatory and quality offerings, the company is well-equipped to deliver cost-effective solutions for both short-term and long-term projects. The expertise provided ensures clients receive high-quality support in navigating regulatory landscapes and maintaining stringent quality control measures. This approach enables businesses to confidently address regulatory challenges and enhance their overall operational efficiency.

Regulatory Quality Business Insights™

AXSource Consulting places a strong emphasis on ensuring the judicious use of business funds to implement tailored compliance measures for its clientele. Through their offering known as Regulatory Quality Business Insights, or RQBI™, the company is dedicated to thoroughly understanding and addressing the unique operational requirements of businesses.

Utilizing a multi-disciplinary approach, AXSource Consulting conducts a comprehensive analysis of the clinical, regulatory, quality, and compliance needs of clients, all viewed through the lens of cost optimization. This approach is designed to facilitate ongoing and sustained value for businesses while simultaneously ensuring compliance with relevant regulations. The focus is on providing efficient and effective solutions that align with the specific characteristics of each business, thus allowing clients to navigate regulatory requirements seamlessly and achieve long-term success. The Regulatory Quality Business Insights offered by AXSource Consulting underscore their commitment to supporting businesses in maintaining compliance while optimizing their use of resources for sustained value.

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 which defines a path for expeditious approval (including any contingencies), aligns 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.

Regulatory Due Diligence

In the pursuit of new business growth opportunities, individuals or organizations may find themselves contemplating the acquisition of a potential product or corporation. In such scenarios, ensuring compliance with regulations and uncovering any potential hidden issues that could jeopardize a deal becomes paramount. Recognizing the significance of this, regulatory due diligence is considered a crucial step.

This meticulous task often demands swift and efficient execution by an independent third party. AXSource Consulting, equipped with a proficient technical team, stands ready to conduct site visits and undertake a rigorous review. Following this assessment, the consulting firm furnishes a comprehensive list of findings, accompanied by a go/no-go decision, a transparent rationale, and potential regulatory pathways with estimated costs.

Whether the focus is on a substantial corporate acquisition or the acquisition of a specific product or product line, AXSource Consulting's regulatory due diligence process serves to equip individuals and organizations with the requisite information to make well-informed decisions.

AXSource Consulting extends a range of services under the umbrella of regulatory due diligence, including the scientific and regulatory assessment of pharmaceutical/biotechnology products, facility compliance assessments, and the provision of scientific and regulatory expert opinions along with professional advice. This comprehensive suite of services reflects AXSource Consulting's commitment to supporting stakeholders in making informed decisions within the regulatory landscape.

Clinical Operations Services

AXSource Consulting Inc. offers indispensable Clinical Operations Services to a diverse clientele, including contract research organizations (CROs), hospitals, clinics, manufacturers, and distributors. The company addresses the critical need for preparedness in the face of regulatory inspections, whether unscheduled or scheduled, recognizing the potential adverse consequences of non-compliance ratings on all parties involved.

Specializing in the development and implementation of effective clinical trial documentation, AXSource Consulting Inc. ensures that its clients are well-equipped to navigate regulatory challenges. The range of clinical services provided encompasses Regulatory Clinical Trial Applications (CTAs), Investigator Brochures, Informed Consent Forms, REB/IRB Approval, Clinical Trial Protocols and study reports, as well as comprehensive Clinical Documentation Development.

AXSource Consulting Inc. goes beyond documentation support by offering essential clinical operations services, including Clinical Monitoring, GCP Audits, Regulatory Inspection Readiness, Remediation Strategy, and Professional Training. The company's commitment to ensuring regulatory compliance and inspection readiness is underlined by its proactive approach in preparing clients for potential inspections and addressing compliance issues promptly.

For those seeking information or assistance with clinical operations, AXSource Consulting Inc. invites individuals and organizations to reach out for more details. The company's dedication to providing comprehensive and effective clinical services reflects its commitment to supporting clients in the successful execution of clinical trials and maintaining regulatory compliance.Top of Form

The Visionary Leader Upfront

Navneet Sekhon is the Founder and President of AXSource Consulting Inc. She is an accomplished Regulatory Affairs & Quality Assurance Executive with over 30 years of international regulatory experience, having 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.

Navneet holds an Honors Bachelor of Science in Biochemistry & 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 & Marketing.

“Our commitment is to empower clients with the knowledge and support needed to navigate complex regulatory landscapes, drive successful acquisitions, and execute clinical trials with precision.”