One of the most demanding aspects of any contract manufacturing project is working with the various regulatory agencies.
Delta Pharma is experienced in working with regulatory agencies and will work with you during all phases of regulatory submission.
You can count on us to coordinate and prepare the necessary documents that are required for all regulatory submissions.
Support documentation may include manufacturing process summaries, component, process, and personnel flow diagrams, client specific equipment and process validation summaries.
- Process validation
- DIN and NHP submissions
- Communications with Health Canada and FDA
- SOP Writing
- Label approval
- GMP Audits