Ask a CMC Expert

After you submit your prickly Regulatory Drug Development enquiry, we will route your question internally and respond shortly with the advice of our SMEs. Our team of expert consultants bring decades of experience to every stage of the regulatory and product development process, from initial selection of development and manufacturing sources, design and evaluation of the investigational manufacturing process thru the scale-up for commercialization to and through approval.

Frequent Questions

What Product Information do you need?
Provide as much product information as possible.
  • Product Name
  • Dosage form (if known)
  • Therapeutic Area
  • Nature of API (ie. Small molecule or biologic)
  • Developmental phase
Who is DSI?
DS InPharmatics (DSI) offers expertise in Regulatory Affairs, Chemistry Manufacturing and Controls & Quality Assurance. Our consultations cover a wide range of real-world experience, focused on quality-based manufacturing, analytical method development, validation and troubleshooting, formulation development, stability strategy and evaluation. In addition our Regulatory Affairs staff ensure that all of the above CMC practices are carried out in agreement with regulatory agencies requirements and expectations.Since such requirements and expectations change with time, CMC regulatory compliance is to ensure that all of the above CMC practices are updated accordingly, in order to ensure that if the company has made any CMC specific commitment to the regulatory agencies, either verbally or in writing, that such CMC practices are carried out.
How much does this cost?