Regulatory & Safety Systems for Pharma & Biotech
Modular Regulatory Solutions
Practical, standards-based software components and advisory to support life sciences teams through master data governance, CMC variations, and safety workflows.
PILLAR 01
ISO IDMP & EMA SPOR Master Data
Structured data models based on ISO 11615, 11616, 11238, 11239, and 11240.
OpenSafety Systems provides tools and methodologies to structure, validate, and align substance, organization, referentials, and medicinal product data with the European Medicines Agency (EMA) SPOR ecosystem and international IDMP standards using HL7 FHIR formats.
Key Functional Capabilities:
Substance (SMS) scientific identifier mapping and substance group taxonomy.
Organisation (OMS) location data and regulatory party alignment.
Referentials (RMS) controlled vocabularies and multilingual term lists.
Product (PMS) medicinal product records and pharmaceutical dose form definitions.
Export capability into HL7 FHIR JSON structures aligned with EMA implementation guides.
Applicable Standards
STANDARDS BODY
ISO TC 215 / ICH / EMA
SPECIFICATIONS
ISO 11615, 11616, 11238, HL7 FHIR
REGULATORY GUIDELINES
EMA SPOR EU IG & FDA 21 CFR 314
Designed for seamless integration into custom or existing pharma pipelines.