Beacon Hill Pharma has a team of Medical Writers that can augment our clients’ existing staff or outsource entire documents for deliverable-based writing assignments. With a diverse set of specialties, our writers have experience with all types of projects.
- CMC/Quality and Quality Summary Sections of submissions
- Nonclinical overview and nonclinical study reports
- Clinical Study Reports (CSRs) and Clinical Summary and Overview
- Integrated Summaries of Safety
- Integrated Summaries of Efficacy
- Safety Narratives
- Annual and Periodic Safety Reports
- Responses to Regulatory Authorities
- Technical Writing
- Publications and white papers
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