SERVICES
Regulatory Submission Documentation
Study Reports
Other

Other

Formatting and/or QC of existing regulatory submission documentation, project management, DMPK (drug metabolism and pharmacokinetics) background...
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Study Reports

Authoring, submission ready formatting and QC of non-clinical and clinical study reports and patient/ safety narratives. Formatting PDF study reports to comply with submission ready regulatory agency guidelines...
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Regulatory Submission Documentation

Authoring non-clinical and clinical sections of: eCTDs, Investigators Brochures, module 2 tabulated summaries, module 2 written summaries, regulatory briefing documents, DMPK query responses, paediatric investigation plan...
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