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ABOUT

Regxia is a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries with extensive experience in Canadian and US regulatory affairs.

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We take a collaborative approach on every initiative, delivering high quality, customized solutions consistent with each client's corporate culture and the ever-evolving regulatory environment. Our client's success is our primary focus.

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Since our founding in 2007 we have been focused on fostering long-term client relationships based on trust, reliability and common values. Regxia's impressive leadership team has the knowledge, insight, and proven experience your business needs to achieve its regulatory objectives.

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Based in Toronto, Ontario our team takes pride in providing quality with every project. Our rigorous employee training and mentoring program sees that each new employee experiences a little of everything and all questions are answered during their training and job shadowing. At Regxia we have one purpose: to ensure our client’s success. We accomplish this using the most innovative approaches in the industry during all phases of a product’s life-cycle.

Toronto, cityscape, city reflection

OUR TEAM

Regxia was founded in 2007 when Betty Cory partnered with Lori de Munnik to provide clients with high quality, customized solutions. Our leaders bring extensive experience and focus to drive investment in our clients that ensures long term, beneficial relationships.

Betty Cory, Regxia's President

BETTY CORY

Co-Founder and President

  • Over 30 years of proven success in the pharmaceutical industry.

  • Experience ranging from pre-clinical research and development through all clinical phases of study.

  • Direct experience with drug, biological and medical device development for international registration.

  • Excellent negotiator with a trusted reputation with key agency personnel.

Lori de Munnik, Regxia's Vice President

LORI DE MUNNIK

Co-Founder and Vice President

  • Exceptional track record in providing regulatory and ePublishing consulting services.

  • Excellent knowledge of the Canadian and US regulatory landscape with a comprehensive understanding of the drug development process.

  • Proven success at strategic planning, coordination and management of NDS/NDA’s, ANDS/ANDA’s, NC’s, and CTA/IND’s.

  • Specific expertise in Chemistry and Manufacturing development and documentation for pharmaceuticals and biotech products.

Tharshini Veerasingam, Regxia's Director RA/QA Operations

THARSHINI VEERASINGAM, B.Sc.(Hons), RAC

Director Regulatory Affairs and Quality Assurance

  • Extensive knowledge of ICH, Canadian and International guidelines gained from regulatory training and experience within the industry.

  • Successful completion of numerous projects have allowed for a strong understanding of the drug development process as it relates to pre-clinical, clinical, CMC, and post-marketing.

  • Guest speaker for the Regulatory Affairs Program at Humber Institute of Technology and Advanced Learning.

Cameron McGregor, Regxia's General Manager

CAMERON MCGREGOR, B.A.(Hons), B.Ed., MBA

General Manager

  • Extensive corporate policy drafting and review experience within academic and private sector businesses.

  • Strong communication and presentation skills with a consultative style tailored for developing long term client relationships.

  • Successful corporate image management across various media venues and social networking sites.

  • Developed and presented comprehensive business and marketing plans targeting strategic corporate growth.

  • Proven success at organizational management and resource optimization.

Amirtha Kavitharan, Regxia's Manager Quality Assurance

AMIRTHA KAVITHARAN, B.Sc.(Hons)

Manager Quality Assurance

  • Extensive experience as a Quality Assurance professional in the Canadian pharmaceutical industry, with a focus on providing consulting services to clients.

  • Skilled in developing, implementing and maintaining quality management systems that meet regulatory requirements and ensure compliance.

  • Proven track record of managing successful Health Canada GXP audits.

  • Demonstrated communication and interpersonal skills, able to effectively collaborate with clients, external partners, and cross-functional teams to ensure project success.

Deepti Kulkarni, Regxia's PV System Supervisor

DEEPTI KULKARNI, MD

PV System Supervisor, RA/QA Associate

  • Key contributor to safety profiling of pharmaceutical products.

  • Subject matter expert for signaling processes and systems.

  • Experienced compliance expert who has a working knowledge of pharmaceutical industry regulations.

  • Extensive experience handling GXP audits.

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