From the implementation of regulations in Canada to emerging international topics such as pharmacogenomics, the regulatory environment is forever changing. Navigating the Regulatory Process™. the constant influx of new information and the evolving regulatory changes is essential in providing expert regulatory support. Spectrum MMC is a company with over 25 years of experience in surmounting regulatory hurdles and staying abreast of changes to come.
International initiatives such as the development of ICH Tripartite Guidelines (International Conference on Harmonization) and the implementation of the Common Technical Document (CTD) have helped harmonize drug development and submission requirements ultimately streamlining the regulatory assessment process for various types of drug submissions. At Spectrum MMC we are familiar with the necessary guidelines, both local as well as international to help guide any submission to successful resolution. Our experience with CTD/e-CTD format is both useful and necessary in achieving the ultimate goal of timely access to the marketplace.
From strategic development to market approval Spectrum MMC has the necessary expertise to drive your project – Drug/Medical Device/OTC-NHP/Cosmetic and related registration activities.
Regulatory Services - Pharmaceuticals
Medical Market Consultants
Managing the Business of Science™
Experience. Service. Quality.
"As an outsourcing partner Spectrum Medical Market Consultants has provided valuable regulatory support in Canada to U.S. and international clients. They have provided services to me for many years and their work effort has always delivered the desired results.
The services ranged from managing a pan-Canadian clinical trial to the preparation and submission of multiple Clinical Trial Applications for various clients. For an innovative New Chemical Entity they provided CMC filling support for NDAs in the U.S. and the EU. The CMC work was carried out over several years that included dealing with commercial partners and numerous third party suppliers.
Spectrum MMC staff are very knowledgeable and are efficient and experienced in navigating the intricacies of government agencies that have oversight for the life science industry. In addition, while always maintaining their professionalism, the staff at Spectrum was always pleasant and friendly.
Spectrum MMC continues to be the first company to which I would go for regulatory support in Canada. "
Vice President, Regulatory
SIGA Technologies, Inc.