President & Founder, AxSource Consulting Inc.
Navneet 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.
As a respected leader in the industry, she has served and chaired several trade association councils, technical and regulatory committees and Boards (MEDEC, PSG, CAPRA, EFC- Medical Imaging Council, RAPS, Parenteral Drug Association, ASQ & ISQA). She has been a speaker for industry trade associationsin government proceedings, workshops, universities and research organizations. Navneet was interviewed by the office of the Auditor General of Canada into improvements in Health Canada. Navneet is a certified lead auditor and knowledgeable in ISO standards and Sarbanes-Oxley business controls.She holds a US patent on development of Microsoft™ based QCS™ Quality & Compliance software. Navneet is very knowledgeable and responsible for litigations (drug/device) and often supports law firms with expert opinions.
Navneet has served on the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA) Board of Directors from 2008-2014. CAPRA is
the premier non-profit organization that serves the therapeutic health product industries in Canada. During her term, she served in many leadership roles including: Chair Marketing & Publications Committee, Executive Advisory Committee, Finance, Vice Chair, and Chair. Upon departure, she was presented with an “outstanding contribution to CAPRA” award.She is also a prior contributing author to the RAPS Fundamentals of Canadian Regulatory Affairs, 2018 (USA).
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.
V.P. Scientific Affairs, AxSource Consulting Inc.
Paul has over 25 years pharmaceutical manufacturing, operations, quality and regulatory experience. He has served as a Director for 20 years, leading Regulatory Affairs and Quality Assurance departments of up to 21 professionals in developing regulatory and business strategies for new products for generic, brand pharmaceutical and medical device companies in Canada.
He is experienced in the preparation of regulatory submissions for pre-assessment, clinical, innovative and generic drugs, having gained approvals for over 200 ANDS / ANDA and 10 NDA drug submissions. Additionally, Paul has significant experience in pre-submissions presentations to Health Canada for biologic and medical device products. He was responsible for over 1200 medical devices and has prepared submissions and maintained compliance for Class 1 through Class IV medical devices.He was also responsible for drug pharmacovigilance reporting, labeling of drugs and devices, provincial registrations to all provinces and narcotic drug handling and distribution.
Paul is also experienced in GMP and has successfully managed a variety of projects including new product development, new manufacturing, and compounding facility construction to post market compliance activities including product transfer and facility wind down & closure, consistently delivering on time and on budget outcomes.Furthermore, he has successfully hosted and supported cGMP / GCP audits by the FDA, HPFBI and EMEA and PV audits by Health Canada.
As a respected regulatory professional, Paul has supported new business development including development of strategic plans and setting up regulatory and quality systems for new businesses, including fabrication, importation and distribution of drug and devices.He has led initiatives to successfully acquire several dozen 3rd party in-licensed products, trained a technical team and developed due diligence tools for risk assessment and qualification of external suppliers.
Paul has excellent communication and people management skills andcan facilitate process change and improvement through insightful assessment, negotiation, planning and project management. He received his Bachelor of Science with Honours in Applied Chemistry from the University of Brighton and obtained his Master of Business Administration (MBA) in strategic management from the Schulich School of Business at York University.
Our team of highly experienced consultants have over 250 years combined experience, on average 25 years’ experience working with global regulatory agencies including Health Canada, the FDA, EMA, MHRA, TGA among others. With a wide breadth of experiences, our consultants bring diverse expertise in various areas including generics, brand pharmaceuticals, medical devices, biologics, women’s health products, opioid pain medications, antifungals, narcotics, oncology, vaccines, monoclonal antibodies, ART / IVF, orphan products, cardiology, and natural health products (NHPs). Our team also consists of French speaking consultants. Whatever your needs, AxSource Consulting will provide you with tailored solutions for your business needs!