Regulatory Affairs & Quality Consulting

Helping Our Clients Achieve Their Goals

About Origin Healthcare Consulting Inc.

Origin Healthcare Consulting Inc. was established in March 2017 and provides Regulatory Affairs and Quality consulting services to obtain Health Canada approvals for pharmaceuticals, biologics and medical devices as well as maintaining approved products in Regulatory and GMP compliance. Our goal is to help healthcare companies develop optimal regulatory strategy, succeed in filing submissions and maintain compliance of marketed products in Canada.


We draw not only on over 20 years of hands on experience in the Canadian environment, but also on the experience of a vast network of the most qualified industry experts.


Mission

Our mission is to assist pharmaceutical, biotechnology and medical device companies through strategizing, filing regulatory submissions and maintaining compliance of marketed products. 


Our driving strength is the deep understanding of the interdependence between various elements of a healthcare company.  We lead the regulatory path while allowing the key growth goals of the company set our direction and achieve success through leveraging experience and entrepreneurial spirit.


Vision

Our vision is to become your partner in creation and growth of your business by incorporating your core values and goals into regulatory strategy.

Your Partner In Growth Of Your Business

Your Partner In Growth Of Your Business

Romina luebke

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President and Founder

Romina has over 20 years of Pharmaceutical industry experience within various areas including both scientific affairs and commercial operations. Romina has worked with several top large and mid-sized pharmaceutical organizations over the years.  


More recently, Romina set up all the systems for a new Canadian affiliate of a global European pharmaceutical company, obtained registration approval for a new prescription drug, launched the new product, established key opinion leader alliance and was the key contact in the transition of the Canadian affiliate after the sale of the global organization.  


Having worked across several functions and setting up various systems where none existed have given Romina the valued ability to see the Regulatory and Quality challenges with a commercial eye and to solve them with an awareness of the impact on all other areas of the business.      


To realize a lifelong passion for creating value and growth, Romina founded Origin Healthcare Consulting Inc. in March 2017 where she helps small and large companies achieve their goals through various projects, including providing leadership to regulatory affairs teams.

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Our services

Regulatory Affairs

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Origin Healthcare Consulting Inc. provides Regulatory Affairs guidance, creation and filing of all types of submissions for drugs and medical devices in Canada.

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Quality Operations

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Quality Operations services to comply with GMP's and all related matters.



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Promotional Material Review

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Review of advertising and promotional materials in alignment with Canadian guidelines.



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Testimonials

"My experience with Romina is that you can be confident your projects will be completed with outmost quality, creativity and efficiency while keeping the business goals in the forefront."

  Ton Van't Hullenaar, Director, North & Central Europe at Mylan n.v. 

"I had worked with several CROs prior to working with Origin Health Care. Romina Luebke was professional, knowledgeable, and expedient. I would highly recommend her to any of my colleagues and I look forward to working with her again."

Dr. Damian Darco-Naqvi

"Romina Luebke provided excellent service and insights to our organization during her assignment with us."

Wendy Adams, General Manager at Galderma Canada Inc.



Contact Us

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We would love to work with you.

We would like to be your partner in achieving your goals. Let us discuss how we can help you with your Regulatory and Quality needs. Please email or call us.  


Phone: (647) 694-3226

Origin Healthcare Consulting Inc.