Consulting Services

For regulated companies, leadership is essential to establish and maintain organizational commitment to quality and for the performance of the pharmaceutical quality system. Proven leadership ability is crucial to carry out difficult decisions in a logical and rational manner by engaging, influencing, and negotiating agreements with team members in a matrixed environment. At Xevalics, we aim to provide impactful consulting services to our clients to support their mission in implement quality systems that maintain a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork within the organization.

When we engage projects, our consultants are experts maintaining a “big picture” perspective without losing sight of the details necessary to meet project deliverables and deadlines. Xevalics brings in broad and deep global health regulatory agency knowledge and experience across US and EU GMP regulations and ICH guidelines with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.

Quality in life sciences industry must account for patient safety, data integrity and other relevant considerations. At Xevalics, we offer a wide range of essential quality, compliance, and regulatory consulting services to resolve your unique operational needs and with customized solutions for you to get the most value-added results.

• SOPs Development
• Content Review/Approval Workflow Definition
• Document Control and Document Management
• Systems Implementation
• GMP Change Management / Impact Assessments
• CSV and IT Quality Assurance