We supply Regulatory Starting Materials (RSMs) aligned with ICH guidance and customer-defined regulatory strategies, supporting robust API filings across global markets.

Our RSM services include:

Clearly defined RSM classification and justification

Controlled sourcing from qualified manufacturers

Documentation aligned with regulatory requirements

Change management and supply continuity planning

Support for DMF / ASMF-linked supply chains

Example RSM categories include:

Defined starting materials for small-molecule APIs

Pharmacopoeial-grade RSMs

Custom-defined RSMs per regulatory justifications

Multi-use RSMs across API portfolios

RSMs linked to DMF / ASMF-supported APIs