Regulatory application planning
Application type and pathway selection — IND, NDA, BLA, ANDA or MAA — mapped to a realistic submission timeline and a module-by-module content plan.
SOP design & governance
Regulatory affairs and regulatory-operations SOPs that hold up under inspection, keeping authoring, review and publishing consistent across a programme and its vendors.
Document planning & CTD structuring
Content plans for each CTD module, with clear ownership, dependencies and review gates set before drafting starts, not discovered during it.
Authoring, QC & eCTD publishing
Drafting and independent quality control of CTD/eCTD components, plus submission-ready formatting, granularity and lifecycle sequencing for health-authority systems.