Pharmaceutical Drug Product Development
Topical Expertise, Client Focus
We are a specialty contract development and manufacturing organization, providing drug product development and testing services to pharmaceutical and biotech companies. We leverage our significant experience in formulation development, analytical methods, manufacturing, and clinical packaging and labeling to move drug products quickly towards regulatory approval.
Based in Northern California, DDL is an FDA-registered, cGMP compliant formulation, development and manufacturing organization that provides expert pharmaceutical product development services to our clients.
Successful Topical Pharmaceutical Drug Product Development Provided by DDL:
Dow Development Labs provided support for the development of Zoryve® (roflumilast) cream 0.3% for plaque psoriasis from inception through to FDA approval in 2022, including formulation optimization, analytical methods development and validation, manufacturing of drug product batches for GLP non-clinical studies, and manufacture, fill, release and stability testing of GMP clinical batches.
We provide topical pharmaceutical drug product development services to our clients – allowing them to rapidly move their programs through development and clinical studies and on to product approval.
Dow Development Labs specializes in:
- Formulation Development & Optimization of Topical Products
- Analytical Method Development & Validation
- R&D, GLP & GMP Product Manufacturing & Filling
- Packaging Compatibility & Stability Studies
- GMP Clinical Supplies Packaging, Labeling & Distribution
- CMC Documentation Support & Product Development Consulting
Our scientists have decades of experience developing, manufacturing and testing semi-solid and liquid drug products. Challenges have been identified and overcome and allow our teams to choose best directions for a product based on past experience.
FLEXIBILITY IS KEY TO FAST-MOVING PROGRAMS
Small, nimble project teams quickly advance programs and adjust activities and time-lines based on client needs.
PROACTIVE AND RESPONSIVE COMMUNICATION
Dedicated project managers and technical team leaders are in constant contact with our clients as programs quickly move forward.