dTk Consulting, LLC located in the San Francisco Bay Area, provides regulatory strategy, development, and submission support to the biopharmaceutical industry.
The principal, David Kashiwase, has over 30 years of experience in drug development and the approval process. He has considerable CMC regulatory expertise and based on his accumulated knowledge/experience can provide a wide range of regulatory support. He has provided support to numerous clients across multiple therapy areas including gastroenterology, inborn errors, anti-infective, oncology, pulmonary, and ophthalmology. David has provided regulatory guidance for the development of small molecules and peptides in a range of dosage forms (e.g., immediate and modified release oral, parenteral [including liposomal], topical, and inhalation) as well as combination products (e.g., inhalation). He has represented numerous clients at FDA meeting or been the regulatory agent for FDA interactions. Additionally, he has experience with local European Health Authorities as well as the EMA.
dTk Consulting can provide hands-on support to successfully complete your projects.
If you would like to learn more, discuss a project, or have questions please contact us.
Telephone: (925) 548-1456