DOSSIER DEVELOPMENT, UPDATION SERVICES
With More than 2000 successful product registration across various Semi regulated markets, Regulatory department of Flamingo has demonstrated its technical capability.
Flamingos customers are also banking on these capabilities in modifying / developing, their registration files (MA files)
As a next endeavor Flamingo has geared up to provide ANDA Development Services for its US Customers
It includes
• Product selection based sourcing options, formulations development & BA/BE studies complexities, commercial viability
• Suppliers qualification and finalisation
• RM, PM procurement for lab development
• Lab Development & lab stability
• External Pilot BE, formulation finalisation
• Tech-transfer to site, Exhibit Batch manufacturing, stability studies
• External Pivotal BE
• ANDA compilation and submission
• RM, PM procurement for commercial launch
• Steady state commercial manufacturing