905.857.3132

info@regulatorysolutions.ca
Offering Reliable, Strategic and Innovative regulatory solutions.

The Team

Jane P. Costaris

Jane P. Costaris

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.

Denise Cheung

Denise Cheung

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.

Yan Lim Wong

Yan Lim Wong

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.

Kate Amaral

Kate Amaral

Regulatory Affairs Manager | 905.857.3132 x105

Kate completed her Bachelor of Science degree at McMaster University in Biochemistry. This was followed by a graduate certificate in Regulatory Affairs at Seneca College during which she interned at Health Canada as a Regulatory Assistant. Kate is glad to have the opportunity to work at Regulatory Solutions Inc. (RSI) as a Regulatory Affairs Associate where she can expand and apply her knowledge of Canadian regulatory requirements.

Sara Ludeen

Sara Ludeen

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!

Lora Anupol

Lora Anupol

Regulatory Affairs Associate | 905.857.3132 x110

Lora Anupol graduated from the University of Toronto with an Honours Bachelor of Science where she specialized in Biological Anthropology with a major in Biology. She later attended Humber College for the Regulatory Affairs postgraduate program. Lora is very eager to be working for Regulatory Solutions Inc. (RSI) and is excited to enhance her skills and knowledge in various regulatory submissions. In Lora’s free time, she enjoys travelling, the outdoors, and watching movies.

Claudia Marucci

Claudia Marucci

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.

Anna Verghese

Anna Verghese

Pharmacovigilance and Regulatory Affairs Associate |

After completing her medical degree (MBBS) and post graduate (MD) degree in Medical Biochemistry, Anna worked as a medical practitioner, Clinical Biochemist and taught the subject at a medical school in India. Anna is in the Regulatory Affairs and Quality Operations program at Seneca College. She is excited to work as a Pharmacovigilance and Regulatory Affairs Associate at Regulatory Solutions Inc, as it provides an excellent opportunity to gain experience and knowledge of the regulatory and drug safety requirements in Canada.

Heba Amra

Heba Amra

Junior 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.

Claire Costaris

Claire Costaris

Part Time 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. Currently, Claire is attending the University of Guelph where she is completing a Masters in French studies. In her spare time, she enjoys reading, baking and hanging out with friends and family. She is excited to be working for Regulatory Solutions Inc. and to learn as much as she can about the intricacies of the regulatory industry!

Elaine Atkins

Elaine Atkins

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.

Jason Cheung

Jason Cheung

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).

Alex Vikhrov

Alex Vikhrov

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.