Sequoia
Syner-G BioPharma Group, formerly known as Sequoia Biotech Consulting, is a leading life sciences consultancy dedicated to supporting life science companies in their mission to advance human health. They provide expertise in therapeutics, diagnostics, and medical devices, emphasizing a collaborative, people-first approach to deliver high-quality therapeutics, diagnostics, and medical devices efficiently. With over a decade of experience, they focus on operational excellence, scalable solutions, and fostering innovation across the entire development lifecycle.
Industries
Nr. of Employees
medium (51-250)
Sequoia
Encinitas, California, United States, North America
Services
Quality systems consulting
Advisory and implementation services for QMS, audits, data integrity and regulatory compliance programs.
Commissioning, qualification and validation services
Execution of CQV programs and method validation for facilities, equipment and analytical methods.
CMC and technology transfer support
Support for CMC development, process scale-up and technology transfer between development and manufacturing environments.
Facilities and lab operations support
Facilities engineering, equipment maintenance, CMMS implementation, and 24/7 operational support for labs and GMP facilities.
Project and owner's project management
Program and project management services for facility builds, expansions and technical programs.
Vendor and CDMO selection and qualification
Processes and frameworks for selecting and qualifying contract development and manufacturing partners.
Quality systems consulting
Advisory and implementation services for QMS, audits, data integrity and regulatory compliance programs.
Commissioning, qualification and validation services
Execution of CQV programs and method validation for facilities, equipment and analytical methods.
CMC and technology transfer support
Support for CMC development, process scale-up and technology transfer between development and manufacturing environments.
Facilities and lab operations support
Facilities engineering, equipment maintenance, CMMS implementation, and 24/7 operational support for labs and GMP facilities.
Project and owner's project management
Program and project management services for facility builds, expansions and technical programs.
Vendor and CDMO selection and qualification
Processes and frameworks for selecting and qualifying contract development and manufacturing partners.
Expertise Areas
- Quality systems and regulatory compliance
- GMP manufacturing operations and scale-up
- Facilities engineering and CMMS
- Commissioning, qualification and validation (CQV)
Key Technologies
- GMP manufacturing processes
- Commissioning and qualification protocols (CQV)
- CMC process workflows
- Process automation and control systems