Topical Drug Product Development and Manufacture
As part of our turnkey CRO solution for our clients, Symbio’s subsidiary, Dow Development Laboratories (DDL), specializes in the design, development and manufacture of topical drug products. DDL is FDA-registered and cGMP complaint, occupying a 23,000 square foot custom-built facility in Northern California.
DDL has expertise and experience developing topical products and medical devices for a wide array of therapeutic indications and containing small molecules as well as proteins, peptides and oligonucleotides. Following QbD principles and always with the patient in mind, DDL supports IND, NDA and ANDA programs.
Areas of Expertise include:
- Topical Drug Product Design and Development
- 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)
- GMP Manufacture and Testing of Clinical Supplies
- Clinical Packaging, Labeling and Distribution to Clinical Sites