regulatory

Since 2006, I have been preparing clinical and pre-clinical reports for regulatory submissions. As biomed context, I offer ICH-compliant drafting and publishing (including hyperlinking)

•  CTRs (phase I to IV) including PK analyses
•  subject/patient narratives, e.g. for CTRs
•  protocols
•  IBs
•  DSURs
•  IMPDs
•  research reports

biomed context can also prepare customised ICH compliant document templates as required.