President | 905.857.3132 x101
Ms. Costaris has worked in the pharmaceutical industry in regulatory affairs since 1993. She began her career in this profession as a Regulatory Affairs Associate for The Upjohn Company of Canada then moved to Ferring as a Regulatory Affairs Manager. Several years later, Jane became the Director of Regulatory Affairs for Schein Pharmaceuticals.
Since 2001, Jane has been the President of Regulatory Solutions where both Jane and her team of associates have provided Regulatory Affairs and Quality Assurance services for a variety of pharmaceutical, natural health products and medical device manufacturers here in Canada, the United States, India, China, and Europe.
Jane holds a Bachelor of Science Honours degree in Microbiology from the University of Toronto. Upon graduation, she worked in the field of quality assurance and developed a specialization in the then emerging field of Hazard Analysis And Critical Control Points (HACCP) principals in the food industry. She also has a certificate in Business Administration from Ryerson Polytechnic University (1989).
In addition, Jane was a long time member with the Canadian Association of Professional Regulatory Affairs (CAPRA) Board of Directors.
Jane has enjoyed volunteering with Big Brothers Big Sisters of Peel since 2005.
Senior Regulatory Affairs Manager | 905.857.3132 x103
Denise Cheung is a Regulatory Affairs Manager at Regulatory Solutions Inc.(RSI). She has been with RSI from the beginning, where she started as a Regulatory Affairs Associate. She has dealt with numerous types of brand and generic submissions from start to finish which include ANDSs, NDSs, CTAs, NHP Licence Applications and Medical Device Licence Applications.
Denise holds a Bachelor of Science Honors degree in Cellular and Molecular Biology from the University of Toronto minoring French. She also has obtained her Regulatory Affairs Graduate Certificate from Humber College.
Senior Regulatory Affairs Manager | 905.857.3132 x102
Ms. Wong graduated from the University of Toronto with an Honours Bachelor of Science degree in Biology. In 2011 she completed the Pharmaceutical Regulatory Affairs and Quality Operations program from Seneca College of Applied Arts and Technology with honours. Yan Lim has been a part of Regulatory Solutions Inc. (RSI). since 2010 and is experienced in working with pharmaceutical, natural health products and medical device approvals. Outside of the office she enjoys spending time with family and friends, travelling and exploring diverse cultures and culinary experiences.
Senior Regulatory Affairs Associate | 905.857.3132 x104
Sara Ludeen has a Honours Bachelor of Science degree from the University of Toronto Mississauga where she did a double major in chemistry and biology. Following her undergraduate degree, Sara attended Humber College for the Regulatory Affairs program. In her spare time, she enjoys reading, watching movies and hanging out with family and friends. She is excited to be working for Regulatory Solutions Inc. and to learn as much as she can about the regulatory industry!
Regulatory Affairs Associate | 905.857.3132 x109
Claudia Marucci graduated from the University of Toronto with an Honours Bachelor of Science degree in Cellular and Molecular Biology. Following her degree, she attended Humber College for the Regulatory Affairs program. Claudia is excited to be working at Regulatory Solutions Inc. as a Regulatory Affairs Associate where she can expand her knowledge and gain experience in the regulatory field.
Regulatory Affairs Associate |
Heba graduated from the University of Toronto with an Honours Bachelor of Science in Biotechnology and a double minor in Biomedical Commination and Professional Writing. In 2018, She completed her Project Management certificate from the University of Toronto. Upon her completion of the Regulatory Affairs program at Humber College, Heba joined Regulatory Solutions Inc. (RSI) as a junior associate to learn and gain experience in the regulatory field. In her spare time, she enjoys reading, baking and spending time with family and friends.
Regulatory Affairs Associate |
Ravinder graduated from York University with a B.Sc. Degree in Chemistry and completed a post-graduate certification in Pharmaceutical Regulatory Affairs and Quality Operations at Seneca College.
Ravinder began her career at a CRO mainly focused on bioequivalence studies in human subjects, followed by working in consulting as an importer and distributor of drug products. Prior to joining RSI, her role was managing importation of drugs and NHPs, DIN submissions, 3PL Quality System Management, hosting and leading regulatory and client audits.
Outside the office, she enjoys running, spending quality time with the family and being a health fanatic!
Pharmacovigilance and Regulatory Affairs Associate |
Michael has a Bachelor of Pharmacy (BPharm) degree and a Doctor of Pharmacy (PharmD) degree from the University of Benin in Nigeria. Michael worked as a community pharmacist, hospital pharmacist, and market development executive/manager in Nigeria where he obtained his knowledge and experience in various areas of pharmacy including clinical pharmacy, pathophysiology, pharmacology, pharmacotherapeutics of disease and as well as toxicology.
Michael attended Humber College for the Regulatory Affairs certificate program before joining Regulatory Solutions Inc. as a Pharmacovigilance and Regulatory Affairs Associate and is eager to learn more about Pharmacovigilance and Regulatory Affairs.
Quality Compliance Manager |
Elaine has over 18 years of experience in the pharmaceutical industry and is currently a Quality Compliance Manager for RSI. She started her career as a lab analyst at Cobalt Pharmaceuticals as a key member of the stability team and then moved on to her role as a Validation Specialist. In this position she became an expert in process qualification and validation of solid oral dosages and successfully developed and implemented a cleaning validation program. Her career then led her to consult and work on special projects for Actavis Canada where she then transitioned to the role of Quality Assurance Associate with Allergan Canada.
In her current role she manages the quality systems and product disposition for the importation and distribution of pharmaceutical products to the Canadian market.
She holds a Bachelors of Applied Science in Chemical Engineering from The University of Toronto.
Senior Quality Compliance Associate |
Alex is an experienced quality professional with expertise in importer and distributor GMPs, and management of third-party and contract-manufactured products. He has been working in the pharmaceutical industry since 2010 and has been a QA consultant since 2016. Alex brings over 9 years of experience in product disposition, quality system management, and consulting experience in auditing and quality management of a broad range of products (DINs, NHPs, Biologics, Injectables, solid dosage forms, transdermal systems, gels, OTC, branded, generic products)
Alex has a Bachelor of Science Honours degree in Chemistry from the University of Toronto and a Pharmaceutical QA/QC post-graduate diploma from the Toronto Institute of Pharmaceutical Technology.
Senior Quality Compliance Associate | 905.857.3132 x107
Jason Cheung graduated from Trent University earning a Bachelor of Science Honours degree with a Joint Major in Chemistry and Biology. He started his career in the pharmaceutical industry in 2008, where he worked for a generic pharmaceutical company as a Quality Control sampler and lab analyst performing analytical testing on raw materials and finished product packaging components. Shortly after, Jason joined a brand pharmaceutical company as a Senior Quality Assurance Associate, specializing in quality functions pertaining to product disposition of imported goods for the Canadian market. Jason has over 8 years of experience in managing quality reviews in various product types (DINs, NHPs, Medical Devices, Biologics, Radiology, Pesticides).
Quality Compliance Regulatory Affairs Documentation Specialist |
Heather Repetski graduated from the University of Toronto earning a Master’s degree in Biotechnology and a Bachelor's degree in Molecular Biology and Genetics. She launched her career as a M. Biotech intern at GlaxoSmithKline in the Medical Affairs department and continued on as a Scientific Advisor. She then transitioned to a role as a Regulatory Affairs Associate where she supported various activities for pipeline and marketed products. Heather has also spent time as a Client Account Manager for a third party logistics company whose clients included manufacturers of pharmaceuticals, medical devices and natural health products. Heather has a keen interest in project management and scientific communications. She is happy to be working with the RSI team serving clients.
Bilingual Healthcare Specialist |
Claire Costaris holds an Honours Bachelor of Science degree from Western University where she did a double major in medical sciences and French linguistics. Then, she obtained a Master of Arts degree from the University of Guelph in French studies. Currently, Claire is attending OISE at the University of Toronto to become a French and Biology teacher. In her spare time, she enjoys reading, baking and hanging out with friends and family. She is thrilled to be working for Regulatory Solutions Inc. and to learn as much as she can about the intricacies of the regulatory industry!