Meet our December Associate Member Spotlight: Optum
The “Associate Member Spotlight” is a chance for CHP Canada to highlight to Active members and the consumer health products industry the Associate members who have contributed to the achievements of CHP Canada and the success of the consumer health products industry as a whole.
Each month a different Associate member, who has engaged in the Association’s member programs (attends networking events, sponsorships, participates in relevant committees, task forces, etc.), will be put in the “spotlight”. This will include being featured on our website homepage, blog, and newsletter, outlining the fantastic services and/or products the Associate member has available to our Active membership.
This month’s “Associate Member Spotlight” goes to Optum for their continued contributions and involvement with CHP Canada and the consumer health products industry. Congratulations Optum!
We conducted a short interview with Mary Speagle, Executive Director, Canadian Regulatory Affairs at Optum, which will provide a better understanding of what this great company has to offer:
1. Tell us about Optum:
Optum works with a diverse range of Canadian, as well as international, clients to support regulatory, quality and pharmacovigilance compliance. Our teams include experts dedicated to specific areas such as clinical trials, pharmaceutical and biologic marketing authorizations, medical devices, natural health products, foods, cosmetics, new substances (chemicals, polymers, organisms) and electronic publishing, as well as generalists to offer flexibility in client solutions. Well networked within the Canadian community and with access to specialized expertise across the international Optum teams (US, Europe, Latin America and Asia), we are well positioned to offer comprehensive solutions. In addition to our core regulatory, quality and pharmacovigilance offerings, we provide complete product development consulting, including both tactical and strategic development plans and development risk assessment. This includes due diligence and evaluation of both in-licensing and out-licensing opportunities. Optum not only offers comprehensive regulatory expertise – it delivers cohesive teamwork that gets results.
2. What are the biggest challenges that you face as a regulatory affairs consulting company in Canada?
One of the biggest challenges that we face providing consulting services in Canada is meeting local needs within the broader global context with increasingly complex and every changing requirements.
With Canadian origins, Optum (formerly CanReg, Inc.) has a long history of operations in the Canadian regulatory consulting business, and has been historically known as a provider of Canadian regulatory expertise. We have changed over the years, becoming more global and offering a broader range of services.
With well networked staff having a range of specialized expertise (pharmaceutical, biologic, food, natural health product, medical device, cosmetic, environmental, CMC, quality, and pharmacovigilance), as well as regional expertise, we are able to provide informed solutions that not only take local, but also global needs into account.
3. Tell us one thing about Optum that the consumer health products industry might not know about you?
Optum offers a broad range of solutions including Rx-to-OTC switch strategy and submissions, product assessments, site licensing and quality system support, Natural Health Product licencing, medical information and pharmacovigilance services, new substance assessments and notifications, Chemical and Polymer Comprehensive Compliance Assessment Tool (CAPCCAT) subscription services, electronic publishing, and development and maintenance of client document repositories (i.e., lifecycle management database).
4. Tell us how you became involved with CHP Canada?
We first became involved as members when our Canadian office was established under the CanReg banner. We have continued this tradition over the years with a switch to the Optum name following our acquisition over five years ago.
If you would like more information on Optum, please visit their membership profile page on our website.
Want to learn more about the Associate Member Spotlight?
Contact Sherri Sheney at the CHP Canada office.