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ISS Inc.’s team of experienced and advanced degreed pharmaceutical professionals provides the highest quality medical writing services, including:
- Standard Operating Procedures
- Investigator’s Brochures and Updates
- Investigational New Drug (IND) and IND Annual Reports
- Clinical Study Reports
- Journal Publications
- SAE Narratives
- NDA Summaries: Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), Clinical Pharmacology, Benefit/Risk, and Non-Clinical Pharmacology and Toxicology
- Literature Reviews
- 120-Day Safety Update Reports
- Post-Marketing Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Reaction (ADR) Reports
- Written Responses to Regulatory Questions
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