Penny Jue

Dow Development Laboratories, LLC (DDL)

Dow Development Laboratories (DDL) designs, develops, tests and manufactures topical drug products, including creams, gels, ointments, pastes, solutions, and suspensions. The company has specialized expertise in formulating small molecules, peptides, proteins, new chemical entities, combination products and generics. The project teams apply their topical product development experience and customer service focus on clients' programs, taking a concept through formulation development, screening, non-clinical studies and clinical supplies, toward successful regulatory approval. DDL has extensive expertise in the following areas: Formulation Development and Optimization, following QbD principles and always with the patient in mind Analytical Method Development and Validation R&D, GLP and GMP Clinical Supplies Manufacturing Clinical Labeling and Distribution ICH Stability (reach-in and walk-in chambers) In Vitro Release Testing (IVRT) CMC Program Strategy and Pharmaceutical Development Reports