Categories

Promotional rules, labeling use, medical information, and compliance expectations

Biologic pathways, biosimilarity, interchangeability, and advanced therapy concepts

ICH GCP, protocol, amendments and trial conduct

Chemistry, Manufacturing and Controls terminology

Drug–device combinations, device constituent parts, and software/device considerations

CTD/eCTD structure, lifecycle, validation, and electronic submission operations

Centralised/DCP/MRP procedures, EMA committees, and EU regulatory processes

Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, PRIME, and similar pathways

Formal meeting types, advice, and sponsor–FDA communication pathways

WHO, reliance, harmonisation concepts, and cross-region submission practices

Good Manufacturing and Distribution Practice

Key ICH guidelines commonly cited in submissions (clinical, quality, multidisciplinary)

Pre-approval, for-cause and routine inspections

SmPC, PIL, Package Insert and labeling requirements

PSUR, RMP, post-marketing commitments

Target product profile, indications, lifecycle strategy, and regulatory intelligence

Terms related to IND, NDA, BLA, MAA, CTA and submission types

Review clocks, milestones, and response packages in review cycles

Type IA, Type IB, Type II and change control