Validation

• GMP Risk Analysis/ Audits

• Validation Master Plans

• Factory Acceptance Tests

• Commission Testing

• Equipment Qualification (DQ/IQ/OQ/PQ)

• Standard Operating Procedures

• Implementation of above- mentioned protocols

• Site License Application (SLA)

Production/ Process Engineering

• cGMP Consulting

• Conceptual Design

• User Requirements Specifications

• Functional Design Specifications

• Equipment Specifications

Project Management

• Project and Resource Plans

• Cost Control

• Contract Specifications

• Design and Procurement Mgt.