February 7, 2024

Long-term FSP Partnership Facilitates Expansion from China to the US

Morula Health’s expert team of writers and flexible approach help Chinese biotech prepare for IND submission Background: A Chinese biotech focused on infectious diseases needed a flexible, long-term medical writing partner to help with documents for submission to the FDA ahead of their upcoming IND. They had in-house medical writing capabilities however this was mainly…

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Morula Health

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

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