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Medical Writing

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Protocol writing detailing study objectives, design, methodology, and statistical methods in CTD format.
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Phase I Clinical Study Reports developed in accordance with ICH E3 guideline for first stage testing in human subjects, “Close-out” study reports, safety reports, etc.
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Phase II/ III Clinical Study Reports, full CTD-format clinical efficacy & safety reports
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Common Technical Document
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Quality Pharmaceutical Documentation
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Safety Summaries
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Toxicology Studies
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INDs, NDAs, other regulatory documents
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Abstracts, posters and slide presentations
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Journal articles, literature reviews and white papers



We can also develop and implement your communication strategies.

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Malvern Consulting Group 490 Lapp Road,
Malvern, PA 19355