Regulatory strategy should not be treated as an activity that begins immediately before filing. It can influence product selection, formulation strategy, analytical development, manufacturing processes and clinical development from the beginning.
A global development program may need to consider target markets, regulatory pathway, CMC requirements, DMF strategy, bioequivalence, clinical requirements, manufacturing-site readiness, stability requirements, technology transfer and inspection readiness.
FTF Pharma describes support for ANDA, ANDS, Marketing Authorizations through DCP/CP/MRP, 505(b)(2), pre-NDA preparation, DMF/COS evaluation, mock audits and CMC/BE/clinical-trial strategy.
When regulatory strategy is integrated with pharmaceutical development from the beginning, companies can make better decisions around formulation, manufacturing, documentation and clinical development, potentially reducing rework later in the program.
