Select your language

Providing essential post-approval support

Providing essential post-approval support


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.


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.

Start your journey with G&L

Discover what G&L can do for you today.

Related Case Studies

Find out more about the solutions we provide to meet the biggest challenges in global healthcare.

Ready to reach your potential?

Discover how G&L can help you do business better

Contact Us