DDL is the topical drug product development arm of Symbio, LLC, a specialty clinical research organization with extensive expertise in conducting clinical studies in dermatology and other therapeutic indications for pharmaceutical, generic and medical device companies.
Located in Northern California, DDL occupies a 23,000 square foot cGMP compliant facility, designed for formulation development, manufacturing, filling, testing and packaging of topical drug products. The formulation, analytical, production, quality and clinical labeling groups have decades of experience moving products quickly toward regulatory approval. Always with the patient in mind and following QbD principles, products are tailor made for the selected therapeutic use, physically and chemically stable, and cosmetically elegant.
DDL excels in the following areas:
- Formulation Design, Development and Optimization
- Process Development and Optimization
- Analytical Method Development and Validation
- In Vitro Release Testing
- Stability Studies and Package Compatibility Evaluations
- Clinical Supplies Manufacturing, Filling, Packaging and Labeling
- CMC Documentation Support and Product Development Consulting