A highly experienced chemistry, manufacturing, and controls (CMC) group that specializes in a wide range of capabilities across the pharmaceutical and medical device fields. The team is adept at providing support and guidance through each phase of your product development. Topical formulations are our specialty.

• Formulation Development
• Analytical methods development
• Process development and improvement
• Packaging development
• Manufacturing scale-up and validation
• CMC reports and section for clinical trials and marketing approval submissions
Responses to FDA Requests

request for proposal

Prosoft Clinical has provided exceptional clinical, data management, CMC, and statistical consulting services on a number of development projects. Their experience and diligence to getting the job right is what distinguishes them from other CROs. I recommend them without hesitation

~ James H Lee MD PhD Group Vice President, Head Inflammation and AutoImmunity Incyte Corporation