Dossier Services

At PDDS India, we understand that navigating the regulatory landscape can be a daunting task. That's why we offer a comprehensive range of regulatory services to help our clients successfully bring their products to market. Our team of experts has extensive experience in regulatory affairs, ensuring that our clients receive the highest quality service and support. We offer a wide range of services

PDDS write (prepare / Draft) and review dossier as per European CTD / ASEAN CTD / ROW-CTD /non-CTD (country specific guideline)

We use latest Pharmacopoeia to prepare CTD Dossier and We strictly do not give our client prepared document to anyone and do not use other dossier data.

CTD Dossier Content 

Module 1 - Administrative Information and Prescribing Information
Module 2 - CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 - Quality (S part - DMF & P Part - Finished Product)
Module 4 - Nonclinical Study Reports (Literature-Based)
Module 5 - Clinical Study Reports (Literature-Based)