Overview
- Project Main Concept Overview
- General User Requirement Specifications (URS)
- Project General Plan and timeline
- Facility Design
- Review the Conceptual Design
- Selection of pharmaceuticals MEP Engineering Consultant to prepare the basic and detailed design
- Machinery Selection & Procurement
- Equipment’s General User Requirement Specifications
- Equipment’s Capacities and automation level
- Find the proper supplier for equipment and utilities list
- Request at least 3 Quotations from the approved suppliers
- Construction [MEP Works]
- cGMP Commissioning and Validation
- Progress reports detailing the status of the commissioning and validation activities
- VMP of the new facility to be used as a road map of the validation activities
- Coaching and Support in Qualification & Validation activities
- Documentation and Training
- Setting the Quality Management Systems (QMS) for the quality department
- Setting the Documentation Master Plan (DMP) for each department
- Setting the Standard Operating Procedures (SOP) and support the client Quality team
Other Services
Technology Transfer
Supporting full technology transfer activities, including: • Transfer of products, processes, and knowledge between sites • Digital transformation of
Toxicological Reports
More than 1,900 PDE / ADE reports