This requirement is for Regulatory affairs EU market. Only M. Pharm with specialization of Pharmaceutics and Pharmacology candidates are eligible.
1. Compilation and review of the dossiers for Oral solid and liquid dosage forms in eCTD format for submission in European union
2. Review of TTD documents such as Specifications (Drug substance and Drug product), Product development report, stability protocols, dissolution protocols, packing plan etc.
3. Compilation of updated dossier (for APL & Customers) & responding to agency comments (MRP/DCP/National)
4. Circulation of approved specifications
5. Review of change controls
6. Maintenance of status (Customer status, DCP-MRP & Renewal time table, Batch sizes, shelf life etc.)