technology
Regulatory-intelligence software
Platforms that continuously monitor REACH, UK REACH, TSCA, CLP, GHS and thousands of related regulatory lists, using AI to filter and prioritize changes relevant to a specific product portfolio.
Where it's used
CMC regulatory consulting (BLA/MAA)
Specialized strategic advisory services guiding biopharma through the complex Chemistry, Manufacturing, and Controls (CMC) requirements to successfully file Biologics License Applications (BLA) and Marketing Authorisation Applications (MAA).
Multi-jurisdictional bio-compliance (FDA+EMA+NMPA+PMDA)
Regulatory-affairs consultancies and eCTD submission software that manage biopharmaceutical filings across the FDA, EMA, China's NMPA and Japan's PMDA simultaneously — helping a biologics or biotech developer sequence and harmonize approvals across the world's major drug-regulatory jurisdictions.
REACH compliance for bio-chemicals
Regulatory consultancies and compliance-intelligence software that register, classify and monitor bio-based chemicals under the EU's REACH regulation — registration dossiers, Only Representative services, and multi-jurisdiction chemical-regulatory monitoring for producers exporting into the EU.