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Writing Solutions
Technical/Regulatory Writing
Preparation of internal and/or regulatory submission documents that are fit for purpose, scientifically sound, aligned with health authority requirements. Some examples of these services include:
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Clinical trial applications
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License applications
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Drug Master Files (DMF)
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Post-approval supplements
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Batch records
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DSURs, annual reports
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Investigations
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Protocols, reports
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SOPs, manuals, job aids
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DEA Quota requests
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Agency meeting requests, briefing books, and sponsor’s minutes
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Responses to agency information requests, clinical holds, and complete response letters
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Dedicated Quality Review Team specific to CMC projects
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