GxP Base
GxP Base is a premier consulting group specializing in building, supporting, and remediating GMP and GLP Quality Systems. With over 50 years of combined experience, they work with pharmaceutical, medical device, and biotechnology companies globally, providing pragmatic and tailored quality system development, auditing, inspection preparation, and remediation services.
Industries
Nr. of Employees
small (1-50)
GxP Base
Services
Design and implementation of GMP/GLP quality management systems and procedures for pharmaceutical, biotech, and device organizations.
Technical and compliance audits of suppliers and CMOs, initial supplier qualification and routine audit programs, including remote audits.
Assessment and remediation planning to prepare organizations for regulatory inspections, including PAI and for-cause inspection support.
Audit and review of design control processes and design history files for medical devices and software-driven devices.
Evaluation and improvement of aseptic processes, cleaning and sterilization programs, and aseptic filling operations.
Validation planning and execution for facilities, utilities, and manufacturing processes, including lyophilization validation.
Design and implementation of GMP/GLP quality management systems and procedures for pharmaceutical, biotech, and device organizations.
Technical and compliance audits of suppliers and CMOs, initial supplier qualification and routine audit programs, including remote audits.
Assessment and remediation planning to prepare organizations for regulatory inspections, including PAI and for-cause inspection support.
Audit and review of design control processes and design history files for medical devices and software-driven devices.
Evaluation and improvement of aseptic processes, cleaning and sterilization programs, and aseptic filling operations.
Validation planning and execution for facilities, utilities, and manufacturing processes, including lyophilization validation.
Expertise Areas
- Quality systems development
- Regulatory inspection readiness
- Supplier qualification and auditing
- Aseptic manufacturing and remediation
Key Technologies
- CRISPR-based gene editing
- Nanoparticle drug delivery
- Aseptic and vaccine manufacturing
- Biosimilar biologics manufacturing