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Providing thorough gap analysis

Providing thorough gap analysis


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.


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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