MEDVACON
Medvacon Life Sciences LLC is a globally recognized leader in FDA Quality, Compliance, and Technical Consulting Services for the life sciences industry. They help organizations navigate regulatory challenges, optimize operations, and manage compliance costs through a comprehensive suite of services including validation, quality systems, IT data integrity, FDA audit readiness, tech transfers, talent acquisition, training, and project management. Founded in 2012, Medvacon is committed to excellence, innovation, and building long-term partnerships to ensure safety, quality, and operational success in pharmaceuticals, biotech, gene therapy, and medical devices.
Industries
Nr. of Employees
medium (51-250)
MEDVACON
San Diego, California, United States, North America
Products
Cleaning Validation Master Plan (example project)
Development of a site-specific cleaning validation master plan following a gap assessment; included risk assessment, protocol templates, sampling strategy, and training for implementation.
Aseptic Manufacturing GAP Assessment (example project)
End-to-end aseptic manufacturing facility gap analysis against EU/UK and FDA expectations with recommendations for environmental monitoring, gowning, media fills, and facility design remediation.
CAPA Backlog Remediation & Investigation Program (example project)
Scaled CAPA investigation and closeout program deploying cross-functional teams to resolve large CAPA backlogs and implement process changes to prevent recurrence.
Cleaning Validation Master Plan (example project)
Development of a site-specific cleaning validation master plan following a gap assessment; included risk assessment, protocol templates, sampling strategy, and training for implementation.
Aseptic Manufacturing GAP Assessment (example project)
End-to-end aseptic manufacturing facility gap analysis against EU/UK and FDA expectations with recommendations for environmental monitoring, gowning, media fills, and facility design remediation.
CAPA Backlog Remediation & Investigation Program (example project)
Scaled CAPA investigation and closeout program deploying cross-functional teams to resolve large CAPA backlogs and implement process changes to prevent recurrence.
Services
Consulting services for QMS implementation, audits, inspection readiness, regulatory remediation, supplier audits, and device/medicinal product compliance.
Services for cleaning validation, process validation, equipment/facilities qualification, and computer system validation using risk‑based approaches.
Process, biochemical, and R&D engineering support for life sciences facilities and manufacturing processes.
Customized cGMP and role-specific training, audit readiness training, and leadership training to improve compliance culture and operator competency.
Program and project management services including rapid project start-up and long-term program oversight for technical and compliance projects.
Candidate sourcing, screening, interview support and placement services tailored to life sciences hiring needs across levels.
Consulting services for QMS implementation, audits, inspection readiness, regulatory remediation, supplier audits, and device/medicinal product compliance.
Services for cleaning validation, process validation, equipment/facilities qualification, and computer system validation using risk‑based approaches.
Process, biochemical, and R&D engineering support for life sciences facilities and manufacturing processes.
Customized cGMP and role-specific training, audit readiness training, and leadership training to improve compliance culture and operator competency.
Program and project management services including rapid project start-up and long-term program oversight for technical and compliance projects.
Candidate sourcing, screening, interview support and placement services tailored to life sciences hiring needs across levels.
Expertise Areas
- Quality management systems (QMS) and compliance
- Cleaning validation and contamination control
- Aseptic manufacturing assessment and remediation
- Computer systems validation and software assurance
Key Technologies
- Computerized system validation (CSV)
- GAMP risk-based validation approach
- Laboratory Information Management Systems (LIMS)
- Rapid microbiological methods (RMM)
News & Updates
Highlighting Medvacon’s role in supporting COVID-19 vaccine development and manufacturing.
Introduction of Laboratory Information Management System services to enhance lab operations.
Best practices shared for computer system validation in regulated environments.
Discussion on cell and gene therapy development, emphasizing partnerships and progress.
Exploration of lean principles in regulated life sciences, focusing on quality, compliance, and efficiency.
Insights into development and innovation in cell and gene therapy.
Highlighting Medvacon’s role in supporting COVID-19 vaccine development and manufacturing.
Introduction of Laboratory Information Management System services to enhance lab operations.
Best practices shared for computer system validation in regulated environments.
Discussion on cell and gene therapy development, emphasizing partnerships and progress.
Exploration of lean principles in regulated life sciences, focusing on quality, compliance, and efficiency.
Insights into development and innovation in cell and gene therapy.