Streamline submissions with unrivaled access to both pre- and post-approval CMC documentation.
Reduce research time with a single source for global chemistry, manufacturing, and controls (CMC) requirements.
Lower regulatory risks with easy access to CMC guidelines for multiple submission types and pharmaceutical forms across 130+ countries, territories, and organizations.
Efficiently track and access official regulations, regional requirements, and local practices for manufacturing, trials, and distribution in select countries, aligning with your needs for both pre- and post-approval variations.
Gain clear visibility into specific CMC requirements for clinical investigations or commercial use with dedicated modules covering both small molecule and biologic requirements across pre- and post-approval stages.
Prepare CMC regulatory dossiers with confidence and submit clinical trial and drug registration applications accurately and efficiently on the first attempt—whether for one country or multiple submissions, with complete end-to-end CMC document coverage.
Customized solutions, powered by extensive expertise in drug commercialization and healthcare, to strengthen your strategy and drive success.
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