Quality Management Systems

Develop and implement global quality management systems in alignment with individual company organization and culture.

GxP Process Mapping and Standard Operating Procedures

Develop GxP inspection-ready standard operating procedure. Expert technical knowledge developing GCP-compliant SOPs, policies and controlled forms and templates

GAP Analyses

Perform GAP assessments of current quality management systems and provide resolutions for continuous improvement for inspection readiness.

Training

Provide GCP and inspection readiness training including industry trends and lessons learned.

Auditing

Conduct GCP audits including:

• Service provider qualification and for-cause audits
• Company internal integrity audits

Provide creative and proactive solutions for issue resolution and process improvements.

Project Management

Develop and execute project management plans including realistic budget, resources and timelines.  Develop and maintain dashboards for addressing critical path items and adjusting plans to meet goals.