RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
Our team is having experience on more than 960 CTD / ACTD Dossiers & 600 - EU / US CTD dossier
PDDS is one stop solution for all kind of Dossier & RA Services
Our team is having experience on more than 1500 DMFs
We write DMF, S Part of dossier & Closed part and We also provide part of DMF like ROS, SE, Impurity, stability, AMV, PV and Specification, COA & MOA of API
We write, PIL/ PI, SmPC, M2 overviews, BMR/MFR, PV, Stability, AMV, PV, PDR, PSUR; We also provide MoA, COA and Specification of API, Non-active, Packing material, Finished Product
For product registration at MoH, Solving all MoH queries & providing 100% authentic and quality data
CTD - ICH / EU Dossier
ACTD - ASEAN Dossier
ROW Dossier
Open Part DMF
Closed Part DMF
Formulation Development and Analytical validation - all dosage form
We write all module documents i.e. PIL/ PI, SmPC, M2 overviews, BMR/MFR, PV, Stability, AMV, PV, PDR, PSUR etc