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Providing Our Clients With Clinical, Regulatory & Compliance Strategies

Regulatory & Quality consulting is pivotal for successful product development. It ensures compliance with regulations, preventing market entry barriers. AXSource delivers the ideal solution by seamlessly integrating regulatory expertise into new product strategies, ensuring market readiness and success.

Regulatory & Quality

Let us help you navigate the complex and ever-changing regulatory landscape

Our consultants are experts in navigating global requirements and can guide everything from CMC, regulatory, clinical, non-clinical, compliance, importation, licensing, labelling, and more. We have worked with clients all over the world, including start-ups, to large multinational organizations. 

 

Our Leadership

Regulatory & Quality
Navneet Sekhon

President, AXSource Consulting Inc.

An accomplished management executive who has over 30 years of International Regulatory Affairs and Quality & Compliance expertise leading results-driven Project Management, strategic Clinical, Regulatory Affairs, QA/QC initiatives across diverse industries including Pharmaceuticals, Biologics, Natural Health Products, Medical Cannabis and Medical Devices within the R&D, non-clinical (GLP), clinical (GCP), manufacturing (GMP/MDSAP/ISO 13485), logistics/distribution (GDP), post-market (GVP) and medical sales & service environments. 

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Take Advantage of Our Years of Experience

We provide Regulatory & Quality consulting services for many industries and have developed unequaled expertise in a range of therapeutic fields and product types. Our perspective is that of an independent partner to help you succeed – not as an outsider with a conflicting agenda.

Expert Consultancy to Evaluate Your Product

AXSource’s Regulatory & Quality Consulting offers specialized expertise to meticulously evaluate your product. We delve into the scientific and regulatory dimensions, providing insightful assessments to guide your development journey with informed recommendations.

Reduce Your Risk

Ensuring compliance is not just a choice but a necessity. Elevate your regulatory strategy with meticulous gap analysis and audits by our Regulatory & Quality Consulting. We mitigate your risk of non-compliance and ensure adherence to legal standards.

Industries We Serve

Active Pharmaceutical Ingredients (APIs)
Pharmaceutical & Biologics
Medical Devices & Diagnostics
Cosmetics
NHPs & OTC Drugs
Cannabis

Dedicated Industry Solutions

GMP Quality & Compliance​

Quality and Compliance solution for Microsoft D365 to comply with GxP.

D365QCS™

Microsoft D365 Integrated Quality & Compliance ERP Software For Life Sciences Industry
30

Years

of proven regulatory expertise

350

Clients

evolved their marketing & compliance Strategies

15

Countries

served with

Partner with us

AXSource is a life sciences consulting company providing expertise in regulatory & quality compliance services and we are looking for partners like you. Our goal is to grow together. We will support your business objectives while assisting our clients to leap ahead and succeed in their business ventures. Our strategic partners support our clients in business forecasting, sales and marketing, market access, translation services, digital transformation systems, third party logistics, pre-clinical & clinical studies and much more. If you are a life sciences business and you wish to participate, lets talk!

Blogs

Ensure Your Business Stays Compliant and Competitive With Our Expert Guidance!