Meridian BioGroup
Pace Labs specializes in providing tailored scientific staffing support and validation, compliance, and regulatory services for the biotech and pharmaceutical industries. They focus on delivering high-quality, client-aligned solutions with a team of dedicated scientists, aiming to help organizations achieve their milestones through expert validation, compliance, and regulatory services. Their approach emphasizes understanding client needs and delivering practical outcomes, fostering long-term relationships in the biopharma community.
Industries
Nr. of Employees
small (1-50)
Meridian BioGroup
Frederick, Maryland, United States, North America
Services
Validation support including FAT, commissioning, qualification, and on-site validation for facility systems, process equipment, lab/analytical instruments, computer systems, and manufacturing processes.
Technical authoring and review of regulatory submissions and related documents, FDA meeting strategy, project management for IND/CTA/IMPD development, and guidance on expedited pathways.
Third‑party and supplier selection audits, benchmarking and gap analysis, quality improvement initiatives, and preparation for regulatory inspections and critical phase inspections.
Development and delivery of training programs on GxP compliance, quality assurance strategies, report-writing, deviation reporting, and root-cause analysis.
Tailored scientific staffing and placement of dedicated scientists to support laboratory operations and project execution.
Validation support including FAT, commissioning, qualification, and on-site validation for facility systems, process equipment, lab/analytical instruments, computer systems, and manufacturing processes.
Technical authoring and review of regulatory submissions and related documents, FDA meeting strategy, project management for IND/CTA/IMPD development, and guidance on expedited pathways.
Third‑party and supplier selection audits, benchmarking and gap analysis, quality improvement initiatives, and preparation for regulatory inspections and critical phase inspections.
Development and delivery of training programs on GxP compliance, quality assurance strategies, report-writing, deviation reporting, and root-cause analysis.
Tailored scientific staffing and placement of dedicated scientists to support laboratory operations and project execution.
Expertise Areas
- Regulatory compliance and quality systems
- Validation and qualification planning
- Audit and inspection readiness
- Regulatory submission strategy and dossier preparation
Key Technologies
- Commissioning, qualification, and validation methodologies
- Computer system validation
- Risk assessment and gap analysis methodologies
- Regulatory submission authoring and dossier preparation