Changing Regulatory Landscape of preceding and forthcoming Years
In this whitepaper, we have compiled and simplified some of these new policies, revisions, regulatory amendments from registration,labeling, safety reporting, renewal, publishing /eCTD submission of last year and forthcoming years.
First Time Right Filing June 2016
Many large and medium biopharma companies operate in 100+ countries. It’s highly challenging to meet regulatory requirements for product approval of new and generic drug fillings, assuring regulatory compliance, and maintaining lifecycle of regulatory authorizations and established guidelines in these countries.