BioPharma Consulting JAD Group
Biopharma Consulting JAD Group provides solutions and technical support for the FDA regulated industry, specializing in engineering, validation, quality, regulatory compliance, and project management. Founded in 2010, with locations across the US and Puerto Rico, the company aims to help clients succeed through reliable, tailored solutions and long-term partnerships. Their mission is to assist clients in achieving success by providing value-added services in validation, engineering, and compliance, with a vision to become a world-class leader in engineering and validation solutions.
Industries
Nr. of Employees
medium (51-250)
BioPharma Consulting JAD Group
Cambridge, Massachusetts, United States, North America
Products
Paperless validation management software (implemented/support)
Implementation and validation support for paperless validation workflow software used to manage validation documentation and execution electronically.
Paperless validation management software (implemented/support)
Implementation and validation support for paperless validation workflow software used to manage validation documentation and execution electronically.
Services
Facility and equipment design, process engineering, engineering specifications, piping/electrical support, utilities and HVAC engineering, procurement support, and project planning for regulated manufacturing sites.
Validation of software and computer systems, automation engineering, SDLC-based validation, network/IT infrastructure validation, data management, and support for electronic batch records and 21 CFR Part 11 considerations.
Planning and execution of commissioning, integrated validation approaches, FAT/SAT, IQ/OQ/PQ, utilities and HVAC qualification, facilities qualification, and decommissioning support.
Process, cleaning, analytical method, packaging, and equipment validation; development of validation master plans; revalidation and validation maintenance; thermal mapping and airflow testing.
Regulatory gap assessments, document control, SOP development, audits, CAPA/change control management, deviation investigations, and support for regulatory responses and remediation actions.
Laboratory equipment qualification, method transfer and validation, SOP creation and revision for lab instruments, laboratory deviation investigations, and computer system validation for laboratory equipment.
Facility and equipment design, process engineering, engineering specifications, piping/electrical support, utilities and HVAC engineering, procurement support, and project planning for regulated manufacturing sites.
Validation of software and computer systems, automation engineering, SDLC-based validation, network/IT infrastructure validation, data management, and support for electronic batch records and 21 CFR Part 11 considerations.
Planning and execution of commissioning, integrated validation approaches, FAT/SAT, IQ/OQ/PQ, utilities and HVAC qualification, facilities qualification, and decommissioning support.
Process, cleaning, analytical method, packaging, and equipment validation; development of validation master plans; revalidation and validation maintenance; thermal mapping and airflow testing.
Regulatory gap assessments, document control, SOP development, audits, CAPA/change control management, deviation investigations, and support for regulatory responses and remediation actions.
Laboratory equipment qualification, method transfer and validation, SOP creation and revision for lab instruments, laboratory deviation investigations, and computer system validation for laboratory equipment.
Expertise Areas
- Engineering consultancy for biopharma facilities
- Validation and qualification of facilities, equipment, and processes
- Regulatory compliance and remediation support
- Laboratory quality management and analytical method transfer
Key Technologies
- Computer system validation (CSV) and SDLC-based validation
- Automation systems (SCADA/DCS) and control system integration
- Electronic Batch Records / MES
- Thermal mapping and environmental monitoring