Sandra Ireland

CEO |

Sandra is the CEO of RSI and has over 20-years experience in the pharmaceutical, medical device, and cosmetic industries. Sandra began her career working at Novartis and GlaxoSmithKline and then moved into consulting where she’s supported small, medium and large healthcare companies with regulatory affairs, clinical affairs and quality operations. She has worked with local and global manufacturers, importers, distributors, and regulatory agencies in Canada, the United States and Europe.

Sandra received her B.Sc. in Biochemistry and Chemistry from the University of Western Ontario. She also holds a regulatory affairs certification from the Regulatory Affairs Professional Society, a post degree certification in Pharmaceutical Regulatory Affairs & Quality Operations from Seneca College, a Clinical Research Associate Diploma from the Michener Institute in Toronto and an MBA from Athabasca University.

Yan Lim Wong

Senior Regulatory Affairs Manager |

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.

Jo-anne Soltesz

Regulatory Affairs Manager |

Jo-anne is a Regulatory Affairs Manager at RSI and has over 30-years experience in the pharmaceutical and medical device industries. Jo-anne began her career working in quality control and moved into regulatory affairs.  She has worked at several generic pharmaceutical companies at associate levels moving into management roles.  Jo-anne has been the Head of Regulatory in several organizations. She has worked in local and global manufacturers, importers, distributors, and with regulatory agencies in Canada, the United States and Europe. Jo-anne 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.  In addition, Jo-anne has over 5 years of pharmacovigilance experience.

Ravinder Saini

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!

Naema Mateen

Regulatory Affairs Associate |

Naema graduated from the University of Toronto with an Honours Bachelor of Science degree where she did a double major in Neuroscience and Human Biology. Following her degree, she completed the Pharmaceutical Regulatory Affairs and Quality Operations program from Seneca College. Naema is thrilled to be working for Regulatory Solutions Inc. as a Regulatory Affairs Associate where she assists and collaborates in the planning and preparation of regulatory submissions to Health Canada (NDSs, ANDSs, SNDSs, SANDSs, DINA, NCs and CTAs) and provincial governments.

Outside of the office, she enjoys spending quality time with her family and friends, playing sports, and trying new cuisines.

Naema has enjoyed volunteering at SickKids Hospital since 2017.

Kelly Lee

Junior Regulatory Affairs Associate |

Kelly joins RSI in the role of Junior Regulatory Affairs Associate supporting the eCTD publishing and submission preparation activities. 

Kelly graduated from the University of Toronto with a Honours Bachelor of Science, double majoring in Biology and Psychology. She has also completed the Seneca College Pharmaceutical Regulatory Affairs and Quality Operations program. Kelly is very excited to be working at Regulatory Solutions Inc., as a Junior Regulatory Affairs Associate to expand her skills and knowledge in regulatory affairs. When she is not working, Kelly enjoys reading and spending time with her friends and family. 

 

Michael Ayuno

Pharmacovigilance 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.

Daniel Díaz

Pharmacovigilance Associate |

Daniel is a physician who graduated from the National University of Colombia. He has a master's degree in alternative medicine, five years of clinical experience, a solid understanding of the medical field, and a passion for patient safety. He began his career in the pharmaceutical industry in 2015, working in clinical trials safety reporting for a multinational company. In 2018, he transitioned to Clinical Safety and Risk Management, where he applied his clinical knowledge and expertise to improve the safety profile of drugs and ensure patient well-being.

Before joining Regulatory Solutions Inc, Daniel got a post-graduate certificate in Regulatory Affairs from Algonquin College, which has given him a strong understanding of the regulatory landscape and the ability to navigate the complex process of bringing drugs to market.

Ashwini Rajguru

Pharmacovigilance Associate |

Ashwini has a done master’s degree in Pharmacy from the University of Pune, India. She has been in the field of Pharmacovigilance for 7 years. Throughout her career, she has worked in different CROs and gained experience in drug safety, ADR case processing, Health Canada reporting, MedDRA coding, and various software used in Pharmacovigilance. 

She also holds a Post graduate diploma in Clinical Research and Regulatory Affairs from AAPS, Toronto. 

She is excited to be a part of the RSI team.

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.

Alex Vikhrov

Senior Quality Compliance Associate |

Alex is an ASQ Certified Quality Auditor, and an experienced quality professional with expertise in GMP compliance relevant to importation, distribution, and contract-manufacturing. He began his career in the pharmaceutical industry in 2010 and has been a QA consultant since 2016. Alex has over 11 years of experience with Pharma QMS, product releases, as well as consulting experience in auditing and compliance management of a broad range of pharmaceutical and natural health products.

Alex has a B.Sc. in Chemistry and a Pharmaceutical QA/QC post-graduate diploma from the Toronto Institute of Pharmaceutical Technology. 

Olivia Chu

Senior Quality Compliance Associate |

Olivia has been in the pharmaceutical industry for over 17 years and is an experienced quality assurance professional with expertise in GMP compliance relevant to importation, distribution, and contract-manufacturing. Throughout her career, she`s worked for global-leading brand and generic pharmaceutical companies, specializing in the quality functions of various product types (DINs, NHPs, Medical Devices, Biologics, Cosmetics, and API raw materials).

She holds a Bachelor of Science in Biology from the University of Waterloo and a Pharmaceutical QA/QC post-graduate diploma from the Toronto Institute of Pharmaceutical Technology.

She is excited to be working with the RSI team and their clients.

Heather Repetski

Quality Compliance 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.

Celine Dudkowski

Regulatory Affairs and Quality Compliance Associate |

Celine completed her co-op at RSI during Summer 2022 and returns after completing the Pharmaceutical Regulatory Affairs and Quality Operations program at Seneca College. 

Celine graduated from Toronto Metropolitan University (Ryerson University) with a Bachelor of Science in Biology and a minor in Psychology. During her undergrad, she was introduced to the pharmaceutical industry by working at Sanofi Pasteur as a co-op student. Celine also completed a post-graduate certification in Pharmaceutical Regulatory Affairs and Quality Operations at Seneca College. She worked at Regulatory Solutions Inc., as a co-op student during her post graduate education.  During her free time, Celine loves exploring new hiking trails, embroidery, and spending time with her friends and family. Celine is excited to apply what she has learned so far into her role as a Regulatory Affairs and Quality Compliance Associate at Regulatory Solutions Inc

Claire Gouveia

Bilingual Healthcare Specialist |

Claire completed her BSc in medical sciences and French linguistics at Western University. Her passion for languages then led her to study at the University of Guelph where she obtained an MA in French studies. Claire’s prior experience in pharmaceutical communications, and her keen eye for detail, complement her role here at RSI, where she provides accurate French translations and proofreading services to clients across Canada.

 

Fun fact – Claire is also an Ontario certified French and biology teacher who is pursuing her PhD in education at the University of Toronto. Ultimately, when Claire is not planning exciting lessons for her students, or engaging with clients in their preferred language, Claire can be found doing what she loves best, which is spending quality time with her friends and family.