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Our unique hybrid model with bespoke medical writing teams supports biotechs with efficient document delivery.
Learn how we work with biotechsMedical writing services
Morula Health provides professional medical writing services across clinical, regulatory, safety and pharmacovigilance, and medical device programs.
We support global life science organizations with the development of regulatory‑ready documents aligned to FDA, EMA, ICH, and international requirements.
Our service offering reflects the full scope of medical writing needed to progress complex development programs from early phases through approval and beyond.
Our services are delivered by specialist medical writers with deep therapeutic and regulatory expertise.
Regulatory writing
Our team draws on their extensive experience with global regulatory bodies (including FDA, EMA & PMDA) to provide reliable and flexible regulatory writing services. You’ll receive accurate, high-quality deliverables that support your overall strategy.
Our regulatory documents include:
- Meeting Request Letters
- Scientific Advice Meetings
- Briefing Documents
- Orphan Drug Designations (ODD)
- Fast Track Designations (FTD)
- Breakthrough Designations (BTD)
- Accelerated Approvals
- Priority Reviews
- IND/CTA Submissions
- Investigational Medicinal Product Dossier (IMPD)
- Pediatric Plans
- Developmental Safety Update Reports (DSUR)
- Safety Narratives
- Integrated Summary of Safety (ISS) / Integrated Summary of Efficacy (ISE)
- CTD Modules 1-5
- NDA/BLA/MAA Submissions
- Regulatory Responses
Clinical writing
Our experienced Medical Writers use their extensive knowledge across various clinical settings and therapeutic areas to ensure your clinical documentation is of the highest quality.
Our clinical documents include:
- Clinical Development Plans
- Protocol Synopses & Study Designs
- Clinical Trial Protocols & Amendments
- Investigator’s Brochures (IB) & Updates
- Informed Consent Forms (ICF)
- Investigational Medicinal Product Dossier (IMPD)
- Clinical Study Reports (CSR) & Narratives
- CTD Module 5
- CTD Module 2
Nonclinical writing
Progress smoothly through the early stages of development with comprehensive, precise and consistent documentation. Your assigned medical writing team will help you to meet your documentation requirements at every stage.
Our nonclinical documents include:
- Grant Writing
- Nonclinical Reports
- Pre-IND Meeting Request Letters & Briefing Documents
- Investigator’s Brochures (IB)
- CTD Module 4
- CTD Module 2
Medical communications
Effectively communicate your research in the right places without taking focus away from your other programs.
We have expert knowledge of target journals’ unique submission requirements and extensive experience in summarizing complex data into comprehensive narratives to help you maximize the impact of your research.
Our medical communications services include:
- Abstracts
- Posters
- Slide Decks
- Conference Proceedings
- Manuscripts
- Journal Selection & Submission Activities
- Plain Language Summaries
Medical devices
Morula Health provides specialist medical writing support for medical device and IVD companies navigating complex regulatory and clinical requirements.
Our writers have hands‑on experience supporting EU MDR and IVDR submissions, as well as FDA‑aligned documentation, delivering clear, compliant content across the device lifecycle.
Our medical devices services include:
- Clinical Evaluation Plans & Reports
- Clinical Literature Reviews
- Post‑Market Surveillance & PSURs
- Summaries of Safety and Clinical Performance
- Clinical Investigation Plans & Reports
- Investigator’s Brochures & Informed Consent Forms
Safety & Pharmacovigilance
Manage global regulatory requirements with confidence. Our writers have experience across DSURs, PSURs/PBRERs, safety narratives, line listings, and integrated safety summaries, supporting both early‑ and late‑stage development programs.
We understand the critical role safety documentation plays in regulatory decision‑making, inspections, and ongoing benefit–risk evaluation.
Our safety writers support global programs aligned to ICH, EMA, FDA, and international pharmacovigilance expectations.
Our safety and pharmacovigilance services include:
- DSURs and annual reports
- PSURs, PBRERs and PADERs
- Safety narratives
- Risk Management Plans and REMS
- Benefit‑risk assessments
