- • Pre-submission activities including regulatory strategy design
- • Support for Scientific advice for complex or innovative dosage form
- • Marketing authorization application through CP/DCP/MRP/NA
- • Advice for the selection of Reference product to b used in development and Bio-equivalence study.
Product dossier preparation and submission
Our product dossier preparation and submission strategy is to provide a full and comprehensive support to pharmaceutical companies for their new product dossier preparation and timely submission to the UK & European union agencies.
Our comprehensive product dossier preparation and submission activities includes -
