USA/Malaysia/Indonesia/Canada
Area: N/A
Estimated Cost: Confidential
PharmEng provided
technology transfer and start
up services, qualification
services, and cGMP expertise
to help the client conduct three
international technology
transfers and start-up projects.
Responsibilities:
Quality System Gap Remediation
Technology Transfer & Start Up
Cleaning Validation
Computer Validation
Equipment Validation
Process Validation
Quality Assurance
o
DIN/510(K) Submission
Export Certificate
SOPs Development