Consultants
Our Consultants
AxSource consists of team of executive partners, consultants, project managers and specialists who support all service offerings. Our consultants include
Nav Sekhon is an accomplished regulatory affairs & quality compliance expert with over 23 years of international experience leading results-driven project management, Regulatory Affairs, QA/QC initiatives across diverse industries including Pharmaceutical, Biologics, Medical Devices, Natural Health Products, Cosmetics within the R&D, clinical (GCP), manufacturing (GMP), logistics/distribution, sales & service environments. She offers outstanding qualifications in pre-marketing government liaison with FDA & Health Canada, Notified Bodies, legal support, implementation of compliance programs including Quality Management System design to GMP/GLP/GCP/ ISO 13485/ 9001/14001/18001, certified quality auditing, validation (including software system validation), risk management/mitigation and process impr ovement. Nav has been instrumental in leading the joint FDA/Health Canada certification of her first company soon after graduation. Nav has been a consultant for over 14 years and in executive management capacity for over 7 years.
Edmond Hetu is a result oriented consultant with over ten years of experience in validation of computer systems in the regulated GxP industry. Edmond has gained significant knowledge in business process, customer service and support. He has spent several years auditing & supporting training in complex CSV implementations. He has several years experience in preparation of Installation, Operational and Performance Qualifications for CSV programs per FDA requirements. He has been responsible for implementing FDA 21 CFR Par11 (electronic records and signatures) in several companies such as Biovail, MDS, and SNC-Lavalin where he support key pharma client projects. Edmond has a Bachelors of Commerce in Management of Information Systems from Concordia University in Montreal, Quebec. Edmond is fluent in English and French.
Rosie Pandher has experience in several disciplines including marketing, account management, regulatory affairs, quality and clinical research within the healthcare industry. Rosie completed her MBA in Pharmaceutical Management and her experience includes development of customized QMS systems, clinical trials, GMP audits, and regulatory affairs. She is responsible for AxSource's business development activities and is a senior consultant knowledgeable in FDA and Health Canada requirements. Rosie has completed her CRA certification from Kriger Research Centre which is accedited by the International Biopharmaceutical Association. She completed her Bachelors in Life Sciences with Biochemistry Honors.
Steven Tanner B.Sc. (Hons.) effectively demonstrates a highly sought after approach to today's healthcare quality, compliance, training and recruitment needs, now surpassing over 12-years in the industry and having mastered a variety of roles all centred on EU, US and Canadian cGMP, GMP/GxP quality assurance systems, training and global compliance standards. From Eli Lilly in the UK to Merck KGaA in Canada, Pharmanet, Novartis and the McKesson Corporation, Steven has both worked with and partnered with only the top pharmaceutical, research and specialty distribution organizations around the globe. Steven attained a bachelors honours degree in chemistry from the University of Leicester, England, UK, and his industry experiences have included significant mentoring from seasoned government health inspectors. His expertise has included design assurance, development, execution and training of robust and effective quality systems, to aid government regulated organizations in meeting the rigour of everyday and ever changing cGMP, GMP/GxP regulatory compliance requirements.
Murray Brox is an accomplished professional with over 30 years of progressively responsible executive experience in leading the implementation of large multidisciplinary teams and projects. He has led a number of ISO implementation projects, has worked at the Director level with delivery responsibility in a large manufacturing organization and as a lead medical device auditor, registered more than 60 organizations. He has a background in operations management, ERP and environmental project delivery. He has gained this experience in a wide cross-section of business sectors including high technology, medical device manufacture, ISO auditing / implementation, with a number of different manufacturing organizations. With Chemical Engineering and Masters of Business Administration degrees, Murray has also lectured at several Canadian universities as well as taught clients effective auditing of ISO Quality Systems, Medical Device Quality and Regulatory systems for Canada, USA, Japan and Europe. Murray is one of the first Lead Auditors for the Australian TGA.
Michelle Manglal-Lan has over 11 years of working for three global organizations like GE, Siemens and KPMG. With her expertise in how learning & development is conducted within the IT, Healthcare, Energy, Industry and Financial Sectors we are able to help our clients in their Learning & Development needs. Michelle is certified as a Six Sigma Green Belt and studied Adult Education at St. Francis Xavier University. Michelle is affiliated to the Canadian Society of Training and Development (CSTD), the Society of Human Resource Management (SHRM), the Canadian Association for the Study of Adult Education (CASAE) and Recognition Professional International (RPI). Michelle has the required skills to offer your firm the opportunity to provide leadership, management and business skills development to your people at every stage of their career.