Topical Expertise, Client Focus
Our subsidiary, Dow Development Laboratories, specializes in the design, development, and manufacture of topical drug products, so you can go from topical formulation development through final approval with the Symbio touch.
About Dow Development Laboratories
Dow Development Laboratories (DDL) is an FDA-registered and current good manufacturing practice (cGMP) compliant contract development manufacturing organization (CDMO). Occupying a 23,000-square-foot, custom-built facility in Northern California, DDL offers a full spectrum of topical products and medical devices services for a wide array of therapeutic indications, including small molecules, proteins, peptides, and oligonucleotides.
Topical Formulation Development Services
Following quality by design principles and always keeping the patient in mind, DDL supports IND (Investigational New Drug), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application) programs with:
- Topical drug product design and development
- Product testing
- Drug product manufacturing
- Analytical methods development and validation
- Process optimization and package compatibility
- Stability studies (R&D and ICH)
- Manufacture and testing of supplies for GLP studies (up to 40 Kg)
- cGMP manufacture and testing of clinical supplies
- Clinical packaging, labeling, and distribution to clinical sites