Regulatory Affairs
Medical Market Consultants
Managing the Business of Science™
EU Company selects Spectrum MMC to steward Canadian registration. NDS a Winner.
Project: To prepare an NDS for a product that was developed over more than a 20-year period by a European pharmaceutical company without any Canadian regulatory experience.
Details: In addition to the preclinical studies that spanned over 20 years, there were approximately 70 clinical studies which included studies that did not meet the current regulatory standards, re-monitored studies for safety, different formulations and different methods for determining treatment-emergent adverse events. Spectrum MMC identified the deficiencies and worked with the client to obtain missing data. To meet the limited page requirement for the Canadian submission summary, a series of very comprehensive tables was developed containing all of the relevant preclinical and clinical information required for review by the Canadian regulatory authorities.
Result: The final NDS was praised by the regulatory reviewers and used by the client for registration in other countries. Sales in 1st eighteen (18) months in the market were $45 million.
Evaluation of Investment Opportunity
Project: A large pension fund requested a global due diligence evaluation involving commercial and regulatory market assessments for the purpose of investing in a company commercializing NHPs and dietary supplements.
Details: An initial screening of international regulatory and commercial practices was carried out.
Subsequently, Spectrum MMC conducted a thorough review of regulatory submission documents as well as QA and medical information documents in-house. By assessing the scientific platform, regulatory compliance and environmental factors, Spectrum MMC provided the fund with valuable information regarding the investment opportunity.
Result: As a result of the final report the fund invested $10 million in the company, which has successfully launched several products in Canada, U.S. and other international markets.
Experience. Service. Quality.
