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

November 28, 2023

Navigating Regulatory and Medical Writing Challenges in MedTech

Introduction The medical device industry plays a pivotal role in advancing healthcare and improving patients’ lives. From diagnostic tools to life-saving implants, medical devices are a critical component of modern medicine and have a unique set of regulatory and medical writing challenges. Below, we delve deeper into how to overcome some common regulatory challenges faced…

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Morula Health

September 29, 2023

New Office Location, Research Triangle Park

Morula Health Unveils Exciting New Office in North America, Research Triangle Park, North Carolina  Morula Health, a leading provider of scientific and medical writing solutions for the biotechnology, pharmaceutical, and medical device industries, is excited to announce the inauguration of a new office in the esteemed Research Triangle Park (RTP) of North Carolina. This strategic…

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Morula Health

September 27, 2023

Diversity Plans and How to Write Them

An Overview of Diversity Plan and How to Write Them: Guidance for Industry Background and Purpose The FDA recognizes the importance of enrolling participants from underrepresented populations in clinical trials to ensure the safety and effectiveness of medical products for all patients. However, there are persistent challenges and barriers to achieving adequate representation of these…

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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

May 18, 2023

Home is the New Office

Home is the New Office: A Look into the Remote Medical Writing Workplace Changing Work Environments Remember what office life was like before the shift to remote working? We’d all make our way to work, chat with our coworkers, get things done, and then head home to relax. Those were the days… However, in recent…

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Morula Health

April 19, 2023

AI for Medical Writing – Remember Clippy?

AI for Medical Writing – Remember Clippy? Soon to be your new best friend – Morula Health’s perspective Contrary to every other blog out there, I am not going to start with a definition of what Artificial Intelligence (AI) is – you should have a good idea by now if you are reading this blog…

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Morula Health

February 16, 2023

Specialist Medical Writing Partners

Specialist Medical Writing Partners: the best of both worlds As the popularity of outsourced medical writing continues to increase in the Life Sciences industry, partnering with the correct type of vendor is crucial for the successful and efficient development of submission-ready documents. Clinical operations, regulatory affairs, clinical trial managers… the list of roles involved in…

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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

November 14, 2022

Morula Health Charity Donation 2022

Throughout 2022 Morula Health has contributed to the development of many pioneering therapeutics targeting life-limiting diseases such as neurogenerative disorders and cancers. Many of these therapeutics would not exist if it weren’t for the tireless work of charities, and the academic research they fund. We are humbled by the symbiotic relationship within which we exist.…

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Morula Health