Medical Market Consultants
Managing the Business of Science™
Experience. Service. Quality.
Almost
all regulatory documents require the careful analytical review of data
and subsequent compilation of the information into succinct and
comprehensive documents.
Spectrum MMC's professionals possess a solid base in scientific reasoning capable of
interpreting preclinical and clinical results for products from diverse
therapeutic areas. The types of summaries include, but are not limited
to, CTD summaries, Health Canada-specific documentation (bioequivalence
comprehensive summaries [CS-BE], Quality Overall Summaries [QOS-CE
etc.]) and product monographs.
Spectrum MMC has
also generated position statements for assorted projects where
negotiations with regulatory bodies are required. In addition to
written summaries, we have also participated in information sessions
for key opinion leaders (KOLs).
Spectrum MMC has
wide-ranging experience in addressing scientific and regulatory issues
using critical thinking and an analytical approach. Our ability to
evaluate information from the vantage point of a reviewer is a
necessary attribute when navigating the regulatory environment.
Analytical Review of Data
