Most life sciences companies face the same issue often that they faced before. But we have analyzed some top-performing companies and concluded that the secret behind such successful functions is their thorough understanding of regulatory quality compliance.
Reactive compliance is not sustainable. Your company system should shift to strategic quality management that demands forward-thinking, efficiency, and effectiveness. Your team should move fast from being reactive to proactive compliance and Xcel Lifesciences know how to make this possible.
We train your team, set up audits & assessments, and validate your processes and equipment to make sure they’re in compliance with your local, national, and international legislative bodies.
From GxP employee training and procedures to system change documentation, and CAPAs being closed in a timely manner, we will ensure your compliance program is operating at peak performance.
Services we are experts to offer at:
Quality and Compliance Strategy
Audits and Assessments
Validation and Qualification
CSV, CSA, Process, Equipment
SOP Assessment and Development
Global Product Identification
Global Unique Device Identification (UDI)
EU MDR / IVDR strategy and implementation
GxP Training and Education
Managed Services and Staff Augmentation
And many more customized regulatory compliance services