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services overview

Fusionlife Solutions offers a wide range of services in Writing services spanning from individual documents to extensive medical writing programs. Expertise teams to provide high quality medical writing services for the biotech, pharmaceutical and medical devices companies across the globe.

Our Focus Areas

Scientific Writing

Medical educational and training materials
Medical marketing reviews and reports
Literature reviews
Publication planning
Abstracts, Manuscript, Posters, Brochures and Slides
Journal/conference submission

Regulatory Writing

CTD/eCTDs,
INDs, IDEs, NDAs, ANDAs, BLAs, PMA, MAA
CMC/manufacturing reports

Safety Writing

AE/SAE Narratives
Causality Assessments
Analysis of Similar Events
Aggregate periodic safety reporting (PADER, PSUR/PBRER, ASR/DSUR)
ICSR narratives
Dear HCP letters
Risk benefit assessments
Guided Questionnaire
Signal Evaluation reports
Health hazard evaluations

Clinical Writing

Clinical study reports
Informed Consent forms
Clinical Study Protocols, SOPs, Templates
Case Report Forms (CRFs)
Investigator brochures (IBs)
Clinical Development Plans (CDPs)
Orphan Drug Designation (ODD)

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