Insights

A small UK biotech developing a neuro-oncology-specific therapy was preparing for an IND submission, and required extra support with their non-clinical documents (CTD modules 2.4 and 2.6). 

Last week, Morula Health attended BioInfect 2026, the annual infectious disease-focused event hosted by Bionow.

AMR-focused medical writing case study: See how Morula Health delivered consistent, expert infectious disease documentation across 15 projects to support NDA‑ready submissions.

2025 marked a transformative year for Morula Health, one defined by meaningful growth, strengthened partnerships, and the continued delivery of high‑quality clinical and regulatory writing.

A guide for applicants who want to participate in the voluntary program developed by the FDA's Oncology Center of Excellence Are you...

Get it right the first time—with less rework, fewer delays, and more clarity Introduction Biotech teams are often working at full...

EMWA Journal - Volume 34, Issue 1, Rare Diseases Author - Philip Burridge , Julie Eastgate Abstract Recent years have seen the...

Morula Health’s guide to writing a clear and compliant CSR   Clinical Study Reports (CSR) are regulatory documents which provide a comprehensive account of the design, conduct, analysis, methods, and outcomes of a clinical trial. Well-written CSRs help regulators evaluate the safety and efficacy of a drug. Depending on the type of trial, amount/quality of data, and the purpose of the report, different types of CSRs can be written (Abbreviated, Synoptic, Supplemental, etc.). T

Strategic Planning for Accelerated NDA Module 2 Delivery Imagine you’re tasked with writing a Phase 3 Clinical Study Report (CSR), along...

Explore how Morula Health's groundbreaking TaaS model addresses the changing demands of biotech companies In the fast-paced world of...

Learning from other industries: Why reinvent the wheel? Many challenges faced in medical writing, data science, and clinical research are...

Proactively Identifying and Mitigating Risks to Deliver High-Quality Medical Writing Medical writing is a cornerstone of clinical...

From ancient civilisations to modern day EMWA Journal - Volume 32, Issue 4 Author - Lucy Hargreaves This article explores the intertwined...

Understanding the metrics that matter for medical writing success Introduction Medical writing might not be the first thing that comes to...

Key takeaways and how Morula Health is making a difference Antimicrobial Resistance (AMR) remains one of the biggest global health...

Aligning Expertise with Your Unique Needs In the world of biotech, documentation isn't just paperwork—it's the backbone of regulatory...

The critical role of medical writing for regulatory interactions, nonclinical IND sections and preparing for clinical trials The path...

The Key to Exceptional Medical Writing Services Introduction People and processes are the bedrock of success for any service provider....

2024 Highlights Report As we conclude another remarkable year, it's essential to reflect upon the challenges we faced, the successes we...

Ensuring a Seamless and Effective Start to Your Project What is a kick-off meeting? A kick-off meeting is the first official gathering...