Case Study
Strategic Filing.
Regulatory
Filing Strategy
Scenario
EU company with a large drug manufacturing capabilities, wanted to make a major presence felt
across Asia Pacific. Finding the right partner was a challenge
Solution
Each product was studied with respect to six regulatory frameworks to identify the correct pathway and timelines. Filings were planned in a manner that the MAs are received during a pre-defined period
Result
The company saved over two years, brought products faster to the market, ensured competition was at bay while they had leverage on the regulatory pathway and early MA receipt.