Providing thorough gap analysis
Providing thorough gap analysis
Client:
Specialist Pharmaceutical company.
Client Challenge:
Our client required support to develop an EU partner’s drug-device combination product for approval in the US via a 505(b)(2) NDA.
G&L Solution:
Working as part of the client’s team, we conducted a gap analysis of the EU MAA content against current US regulatory requirements and regulatory precedent for similar US-approved products.
We also developed contingency strategies based on potential FDA feedback and NDA preparation has been initiated.
Outcome:
Our partnership has since expanded and grown to include a similar scope (Pre-IND and NDA) for a second 505(b)(2) product.
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