CMC CONSULTING

From start-to-finish, DSI can supplement your in-house team and successfully address your needs at every step of your drug development program.

Our CMC Specialists have a proven track record in the successful development and commercialization of over 40+ small molecule and biological products in a wide range of dosage forms, including dosage; lyophilized; and sterile solutions, topical solutions, inhalation, and combination products.

A dedicated CMC scientist is available to:

• Coordinate and manage contract manufacturers and laboratories
• Draft protocols and design and oversee experiments and studies
• Draft protocols and SOPs
• Review data and interpret results
• Supervise production runs
• Review batch records and COA’s
• Conduct audits
• Draft regulatory