Regulatory Submissions

What We Do

IBTS provides consulting services for small to medium sized pharma and biotech companies in the clinical phase of development, guiding those companies toward commercial market entry by focusing on the CMC manufacturing, compliance and regulatory approval aspects of their product development activities. IBTS has experience with both US and European focused products, in particular at bridging between the markets. IBTS specializes in coordinating with external contract researchers and manufacturers on behalf of our clients.

Please click on the appropriate link to see a more complete list of our capabilities.



Clinical and Commercial Supply
Clinical Development
Product Development
Validation Services
cGMP and GCP Audits
Quality Systems