What We Do

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.

 
 
 

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