Case Study
Strategic Filing.
New Chemical
Entity
Scenario
Client was struggling to make a
NCE submission across ASEAN.
Local Regulations, translations,
filing procedures, MA Holding, and Data Security were a challenge
Solution
We acted as a one-point contact for the target markets, preparing all regulatory packages, translations and made filings. Providing data security & providing MA holding helped achieve objectives
Result
Time saving and data security helped client save years on their plans and increase revenues. Maintaining a competitive edge was possible with the correct regulatory pathway.