Chemicals & Pharma Compliance Documentation Software

REACH registration alone demands documentation dossiers for each substance manufactured or imported above one tonne per year — covering toxicological endpoints, exposure scenarios, risk management measures, and downstream use conditions. With over 23,000 registered substances and the Candidate List of SVHCs growing twice annually, the documentation volume for a mid-sized chemical manufacturer easily runs to thousands of pages. Layer on CLP hazard classification and labelling (Regulation 1272/2008), GMP quality system requirements for pharmaceutical ingredients, and the emerging CSRD sustainability disclosures for chemical sector companies, and regulatory documentation becomes a core operational activity rather than a support function.

Pharmaceutical companies face an additional documentation axis: clinical evidence. FDA 510(k) or PMA submissions, EMA marketing authorisation dossiers, pharmacovigilance adverse event reports, and post-market surveillance data each have their own format, retention, and update requirements. For companies operating across both chemical and pharmaceutical products, the regulatory surface area is exceptionally wide, spanning environmental (REACH, CLP), health (GMP, FDA/EMA), and sustainability (carbon footprint, CSRD) domains.

Sustalium manages chemical and pharmaceutical compliance at the substance and product level rather than at the company level. Each registered substance carries its own REACH dossier record, SVHC status, CLP classification, and Safety Data Sheet. Each pharmaceutical product links to its quality documentation, regulatory submission history, and post-market data. When ECHA updates the Candidate List or a regulatory agency issues new guidance, affected records surface for review — sparing your regulatory affairs team from manually cross-referencing spreadsheet inventories against evolving requirements.