supporting success in drug development
We are a specialized consulting company focused on Chemistry, Manufacturing, and Controls (CMC). Founded in 2018 and headquartered in Stockholm, we operate internationally, partnering with biotech and pharmaceutical organizations worldwide.
We provide strategic direction, operational expertise, and regulatory guidance across the full CMC lifecycle—from early development to market. Our team supports clients in building robust CMC strategies, ensuring regulatory compliance, optimizing manufacturing processes, and navigating complex global regulatory environments.
Chemistry, Manufacturing and Control (CMC)
- Fundamental for drug development, from the early stages through to market approval and future life-cycle management.
- Covers everything from the manufacturing of drug substance to final product formulation and packaging, ensuring that the drug meets required quality, purity and stability standards.
- Ensures adherence to regulatory guidelines set by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Plays a vital role in minimizing risks and reducing costs across all phases of drug development.
Our Services
CMC LEADERSHIP.
lead CMC function for biotech start-ups
DUE DILIGENCE.
scrutinize project documentation for buyers and sellers
CMC CONSULTING.
provide essential expertise to take your project to the finishing line
INTERIM MANAGEMENT.
cover for gaps and maintain operational continuity
SUPPLY MANAGEMENT.
deliver the right amount of product at the right time
REGULATORY CMC.
ensure the right content for your submission
