At the process development/pilot production phase, our chemists develop the process further, determine the range of the critical parameters and determine the safety data. The process is taken into the plant for pilot production runs.

Our goal: To deliver a proven production route that generates the API in consistent batches.

At a minimum you can anticipate the following outcomes as a result of your input combined with our activities:

Input

• Scaleable process
• Validated analytical methods and controls

Activities

• Pilot production run
• “One off” production campaign

Output

• Technical process
• Product
• Master batch records
• GMP documentation as required
• Validated production route with analytical methods