Non-ACTD & CTD/eCTD Dossier (Country Specific)
PharmaActdDossiers service are offering dossier as Non-ACTD & CTD/eCTD Dossier services as per country specific guideline. PharmaActdDossiers service offer a full report writing service. This service is offered where clients’ needs are closely matched to industry documentation conventions.
- Generation of all documentation
- Stability reports compiled in accordance with CPMP-ICH preferred format which leads to ready incorporation into dossier submissions
- Compilation stability testing protocols, validation protocols & Validation reports
- Preparation of DCGI Files & COPP data.
- Dossier Preparation as per MOH requirement. We support till the receipt of Registration certificate.
- PharmaActdDossiers service offer time bound service with authenticate document.