Meet our Associate Member Spotlight for August: Mapi Life Sciences Canada Inc.
The “Associate Member Spotlight” is a chance for CHP Canada to profile the associate members who contribute to the achievements of CHP Canada and the success of the consumer health products industry as a whole.
Each month a different associate member is put in the “spotlight.” This includes being featured on our website homepage, blog, and e-newsletter, outlining the fantastic services and/or products the associate member has available to our members.
This month’s “Associate Member Spotlight” goes to Mapi Life Sciences Canada Inc. for their continued contributions and long-standing involvement with CHP Canada and the consumer health products industry.
We conducted a short interview with Mary Speagle, Executive Director, Regulatory Affairs at Mapi Life Sciences Canada Inc., which provides a better understanding of what this great company has to offer:
1. Tell us about Mapi Life Sciences Canada Inc.
At Mapi,our senior consultants bring decades of experience working across a broad range of product classes and therapeutic areas with Health Canada, the US FDA, the European EMA and other global regulatory bodies and have filed over 30,000 submissions in the last five years alone.
Initially established in Canada under the CanReg banner, we have been providing regulatory, quality and pharmacovigilance consulting services in Canada over more than 18 years. With expertise in regulatory strategy, agency interface, submission filings, Health Canada negotiations through to approval, marketed product support/lifecycle management and critical issue management, we are well positioned to serve our clients.
Canadian services include:
• Clinical trial applications (CTAs) and Canadian agent services
• New drug submissions (NDS, SNDS, ANDS) and DINs
• Prescription (Rx) to over-the-counter (OTC) switch submissions
• Label development
• Natural health product (NHP) and food submissions
• Medical device licence applications
• Cosmetic notifications
• New substancesnNotifications
• Regulatory intelligence
• Advertising review
• Due diligence
Mapi is a full service firm with QA services, including drug establishment licensing, NHP site licensing, medical device establishment licencing, product release, implementation of quality systems and site audits, pharmacovigilance and medical information consulting.
2. What are the biggest challenges you face as a research/consulting company in Canada?
Regulatory consulting has become more complex over the years with a constantly evolving environment. The need for experienced local teams with access to current regulatory intelligence plays an ever increasing role. Dedicated experienced teams with both generalists and specialists are key to providing support across product types and geographies, as is development of local networks to support specific client needs.
As a people-based business, the hiring, developing and retaining of the best consulting talent continues to be key to success of our business.
3. What are some recent trends that Mapi has witnessed in our industry?
• Consumer empowerment and education driving regulatory change
• Electronic submissions
• Increasing regulatory transparency
• Shift from pre-market to post-market oversight (i.e. total life-cycle management)
4. What do you value most about your involvement with CHP Canada?
• Source of intelligence for the consumer health products industry.
• Work with stakeholders on various initiatives including input for policy development.
Want to learn more about the Associate Member Spotlight?
Contact Sherri Sheney at the CHP Canada office.