July 24, 2023

Advancing Cell and Gene Therapy

Advancing Cell and Gene Therapy: A Case Study on Rapid CSR Development Challenges: A pioneering West Coast US Biotech urgently needed to write the CSR and SAE narratives for their Phase 1 cell and gene therapy clinical trial. The client had a tight deadline to submit the CSR to the FDA within a few weeks.…

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Morula Health

February 13, 2023

Repeatedly Unlocking Success

Repeatedly Unlocking Success: West Coast Biotech successfully prepared for their Type B Meeting with timely technical support   Background One of our repeat clients, a West Coast Biotechnology company, needed help with writing and strategic input for their Meeting Request Letter and Briefing Book. This was in preparation for a Type B Meeting with the…

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Morula Health

October 19, 2022

IND to IMPD Adaptation to Open Sites in Europe and Israel

Morula Health’s expertise and quick solution allowed for easy adaptation of an IND to IMPD for one of our clients. Background The client, a US Biotechnology company, was running clinical trials in the US. With these existing trials going well, they wanted to expand their research program. They required a written Investigational Medicinal Product Dossier…

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Morula Health