October 5, 2022
Tackling diversity in clinical trials
Health Canada has introduced a new questionnaire to track the inclusion of disaggregated data on…
Regulatory & Quality consulting is an often overlooked, but essential component of new product development. You go through all the work of developing a product, only to find out it can’t be sold because it doesn’t comply with regulations. In this case, regulatory consulting is essential for making sure your company’s product makes it onto the market.
Let us help you navigate the complex and ever-changing regulatory landscape
We have the expertise and resources to guide your business through each step of the Regulatory & Quality process. Our consultants are experts in navigating global requirements and can provide guidance on everything from registration to labelling, and more. We work with clients all over the world, including start-ups, to large multinational organizations.
Our Leadership
Navneet Sekhon
President, AXSource Consulting Inc.
She is an expert in developing and implementing quality management systems for companies in the pharmaceutical, biologics, medical devices, natural health, and related products industries. She specializes in helping start-ups comply with regulatory requirements and can provide expert opinions for litigation. She is also skilled in conducting and auditing validations, including computer system validation. She holds a US Patent for a software solution that supports quality and compliance in the therapeutic products industry.
- Take Advantage of Our Years of Experience
- Expert Consultancy to Evaluate Your Product
- Reduce Your Risk
Take Advantage of Our Years of Experience
We provide Regulatory & Quality consulting services for many industries and have developed unequalled 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 is an expert consultancy that evaluates and assesses the scientific and regulatory aspects of a company’s product in order to make informed recommendations on how to proceed with development.
Reduce Your Risk
Compliance is a requirement, not an option. It’s time to get serious about your regulatory strategy with gap analysis and audits from Regulatory & Quality Consulting. We will reduce your risk of non-compliance and keep you on the right side of law enforcement.
Industries We Serve
Active Pharmaceutical Ingredients (APIs)
Pharmaceutical & Biologics
Medical Devices & Diagnostics
Cosmetics
NHPs & OTC Drugs
Cannabis
Dedicated Industry Solutions
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
July 7, 2022
Benefits of AI in Pharmacovigilance
Pharmacovigilance, commonly known as drug safety, is the process of collecting, detecting, assessing, monitoring, and…
April 28, 2022
Thank you, Charlotte
Charlotte has an incredible breadth of experience in quality assurance and quality compliance. Since 2013,…
