We write dossiers that meet all national and international requirements and is in accordance with all legal demands.
- Dossier in CTD (modules 1 – 5 or any requisite module) and eCTD formats for worldwide markets like EU, USA, UK,
- Preclinical and clinical Overviews / Summary writing based on literature search / Published studies / articles from journals .
- Dossiers for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form.
- Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements.
- Product information update (SmPC, PIL and Labeling).
- Preparation of Drug Master File and Certificate of suitability (open and closed part)