Consultancy is a specialized service that provides global solutions for the Life Sciences market, looking for the most efficient way to comply with those requirements set by specific regulations. With a network of offices to cover worldwide clients, our experts from many different fields have a practical view having worked in regulated environments that allow us to provide the right approach to fulfil health authorities requirements. From the initial concept starting with an idea, to the final approval by national and international regulators, we will guide you safely in the whole process.
For More Information please visit: https://www.telstar.com/engineering-projects/consultancy/
Telstar Consultancy Service Includes :
Site Master Planning
Feasibility Studies
Conceptual Design
Third Party Quality Audits QA Services:
- Product Quality Review (PQRs)
- Standard Operating Procedures (SOPs)
- User Requirement Specifications (URSs)
- Process validation
- Cleaning validation, clean holding times, dirty holding times
- Deviation management with root cause analysis and CAPA management
- Personalized theoretical and practical training
- Internal audits, GAP analysis and implementation of quality systems according to GMP (EU, FDA) / GDP / ISO 13485 (Medical Devices)
- Preparation and support on FDA Pre – Approval Inspections (PAI)
- Data integrity
