eCTD Publishing and Submissions

PharmaReg supports eCTD (electronic Common Technical Document) submissions to US FDA, European Medicines Agency (EMA) and Health Canada. PharmaReg helps in data compilation, publishing and submission activities.

Pharmareg got the expertise in eCTD submission of:

• New Drug Applications (NDAs)

• Abbreviated New Drug Applications (ANDAs)

• Drug Master Files (DMFs)

• Investigational New Drug Applications (iINDs)

• Structured Product Labelings (SPLs)

• Periodic Adverse Drug Experience Reports (PADERS)

• Ad Promo Submissions

• Lifecycle Management (LCM)

• Amendments and Supplements