Concuir
Consulting firm serving pharmaceutical, biotechnology, and medical device clients. Provides program and project management, technical execution, manufacturing support, and regulatory remediation to enable process transfers, scale-ups, equipment implementation, and product launches.
Industries
Nr. of Employees
small (1-50)
Concuir
Laguna Hills, California, United States, North America
Products
Program & Project Management
Hands-on management of programs and projects through building relationships between clients and external resources.
Technical Project Execution
Support for executing complex projects on schedule and within budget.
FDA Warning Letter & 483 Remediation
Strategies to resolve complex regulatory nonconformance issues and achieve compliance.
Aseptic Fill-Finish Installation
Project management and technical expertise for aseptic fill to finish processes.
Process Optimization
Optimization of filtration and purification processes to maximize production efficiency and minimize cost.
Process Scale-Up
Streamlining the scale-up of pharmaceutical and biotech manufacturing processes to ensure timely product delivery.
Program & Project Management
Hands-on management of programs and projects through building relationships between clients and external resources.
Technical Project Execution
Support for executing complex projects on schedule and within budget.
FDA Warning Letter & 483 Remediation
Strategies to resolve complex regulatory nonconformance issues and achieve compliance.
Aseptic Fill-Finish Installation
Project management and technical expertise for aseptic fill to finish processes.
Process Optimization
Optimization of filtration and purification processes to maximize production efficiency and minimize cost.
Process Scale-Up
Streamlining the scale-up of pharmaceutical and biotech manufacturing processes to ensure timely product delivery.
Services
Hands-on program and project management, governance setup, stakeholder alignment, risk and schedule management for life-science projects.
Management of CMC activities including analytical coordination, regulatory timeline tracking, resource planning, and vendor management to support early-phase development.
Project management and technical oversight for transfers between sites and organizations, including method harmonization and logistics oversight.
Project and technical support for procurement, installation, vendor coordination, and validation of aseptic fill–finish manufacturing lines.
Consulting for equipment selection, implementation planning, cycle development, troubleshooting, and sustainment across production equipment.
Support for scaling lab processes to clinical or commercial manufacturing, including bench-scale review, parameter verification, and selection/testing of process equipment.
Hands-on program and project management, governance setup, stakeholder alignment, risk and schedule management for life-science projects.
Management of CMC activities including analytical coordination, regulatory timeline tracking, resource planning, and vendor management to support early-phase development.
Project management and technical oversight for transfers between sites and organizations, including method harmonization and logistics oversight.
Project and technical support for procurement, installation, vendor coordination, and validation of aseptic fill–finish manufacturing lines.
Consulting for equipment selection, implementation planning, cycle development, troubleshooting, and sustainment across production equipment.
Support for scaling lab processes to clinical or commercial manufacturing, including bench-scale review, parameter verification, and selection/testing of process equipment.
Expertise Areas
- Program and project management
- CMC project management
- Technology transfer
- Aseptic fill–finish implementation and commissioning
Key Technologies
- Tangential flow filtration (TFF)
- Column chromatography
- Lyophilization
- CIP/COP/SIP cycle development