Our experienced CMC regulatory affairs consultants combine in-depth technical knowledge of product development with risk-based submission content and regulatory strategies for all phases of the review and approval process.
We offer complete Chemistry, Manufacturing and Controls (CMC) consulting services to pharmaceutical and biopharmaceutical companies.
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
Contact us for more information on how we can help with your Chemistry, Manufacturing and Controls (CMC) needs.