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Providing essential post-approval support

Providing essential post-approval support

Client:

Gene Therapy company.

Client Challenge:

Our client engaged us to provide a range of regulatory services in support of their Phase I and II programs. This covered a range of disease areas including the Central Nervous System, Rare diseases, Hereditary, Inflammation, Oncology and Addiction disease areas.

G&L Solution:

We authored IND content for non-clinical, clinical, and CMC.

We also provided strategic advice and prepared the applications for Orphan Drug Designation and Breakthrough Therapy Designation, before conducting eCTD publishing and FDA filing via G&L’s ESG Gateway.

Outcome:

This long-term partnership has seen us support the client’s entire portfolio over a number of years.

It showcased the breadth of G&L’s gene therapy expertise comprising CMC, medical writing, regulatory strategy, as well as therapeutic area knowledge and eCTD publishing capabilities.

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