Software and specialist solutions for modern regulatory affairs.
OpenSafety Systems helps pharmaceutical and biotech teams manage ISO IDMP data models, evaluate regulatory CMC variations, and streamline safety operations with clarity and precision.
Core Areas of Focus
Focused tools and advisory built around published international regulatory standards.
ISO IDMP & EMA SPOR Data Models
Structure substance, organization, referentials, and medicinal product master data according to ISO 11615, ISO 11616, and EMA SPOR guidelines.
Regulatory CMC Change Control
Evaluate pharmaceutical manufacturing changes, formulation adjustments, and specification revisions against EMA and FDA variation frameworks.
Regulatory Information Management
Maintain clear visibility over marketing authorizations, regulatory commitments, health authority queries, and dossier lifecycle milestones.
Pharmacovigilance Support
Structured workflows for adverse event intake, standard medical dictionary coding (MedDRA, WHODrug), and E2B(R3) case processing.
How OpenSafety Systems Works with Teams
Whether you need automated data structuring software or hands-on regulatory data mapping, our platform provides a modular starting point.
SPOR & IDMP Structuring
Transform disparate product listings, Excel tables, and legacy dossiers into validated HL7 FHIR JSON structures compliant with EMA SPOR.
Variation Classification
Assess site transfers, manufacturing adjustments, and specification revisions against official EMA and FDA variation guidelines.
Implementation Guidance
Collaborate with our team on data migration planning, system integration, and regulatory technical documentation.
Discuss your regulatory data requirements
Get in touch to walk through our ISO IDMP data models, CMC change templates, or discuss tailored integration with your workflow.