How do you develop a regulatory strategy for a novel biologic?

Regulatory strategy aligns development with approval requirements across jurisdictions: 1) Early planning - define Target Product Profile, regulatory pathway (standard vs accelerated), and global filing strategy. 2) Regulatory designations - orphan drug (7-year exclusivity US, 10 EU), breakthrough therapy (intensive FDA guidance), PRIME (EMA), fast track, accelerated approval based on surrogate endpoints. 3) Agency interactions - pre-IND meetings, Type B meetings, scientific advice; align on endpoints, patient populations, comparators, manufacturing requirements. 4) Clinical development - adaptive designs, master protocols, real-world evidence; negotiate registration-enabling trial designs. 5) Chemistry, Manufacturing, Controls (CMC) - phased approach to controls; comparability for process changes; establish acceptable specifications. 6) Global harmonization - ICH guidelines alignment; reference product selection for biosimilars; address regional differences (China NMPA, Japan PMDA requirements). 7) Post-market commitments - REMS, Phase IV studies, label updates. Risk-based approach prioritizing critical path elements.