Soltima is a South San Francisco-based company dedicated to serving the biotech community. We customize regulatory content management / regulatory data integrity solutions tailored to specific organizational requirements.
We specialize in:
Analytical Operations – Solutions for bioanalytical data characterization using a variety of analytical/visualization tools.
Laboratory Operations – Solutions for global regulatory submissions including IND, NDA, BLA, CMC for both small and large molecules.
Regulatory Content Development/Management – Solutions for handling SDLC and Document Life Cycle objective evidence creation and management.
Regulatory Data Integrity Management – Solutions for Business Rules/Requirements; Data Governance, Data Quality, Data Storage/Retention, and Data Controls/Movement.
Building custom, bespoke, auditable, and quality solutions is our bridge to meeting your regulatory needs cost-effectively.