Quantisage’s Medtech and Pharmaceuticals consulting services are designed to navigate the intricate landscape of innovation, regulation, and market demands. We empower organizations to accelerate product development, ensure stringent compliance, and optimize operational efficiency. Recognizing the rapid evolution of technologies and the increasing complexity of global regulations, we provide tailored solutions that address the unique challenges of this sector. From streamlining R&D and manufacturing processes to implementing robust quality management systems and navigating regulatory submissions, we help clients bring life-changing products to market faster and more effectively. Our focus is on fostering innovation while maintaining the highest standards of safety, quality, and compliance, enabling our clients to achieve sustainable growth and improve patient outcomes.
Accelerating research and development, ensuring GxP compliance (GAMP5, 21 CFR Part 11), and optimizing manufacturing processes.
Solutions:
Oracle Life Sciences Cloud: Implementation and validation of Oracle Clinical One, Oracle Argus, and other solutions for clinical trials management, pharmacovigilance, and regulatory submissions.
GxP Validator: Automated validation for laboratory information management systems (LIMS), manufacturing execution systems (MES), and other GxP-regulated systems.
AI-Powered Document Management: Streamlining regulatory submissions and audit preparation.
Supply Chain Optimization: Ensuring traceability and compliance throughout the product lifecycle.
Data Integrity & Compliance: Implementing ALCOA+ principles and ensuring data security.
Focus: Ensuring compliance with FDA regulations (21 CFR Part 820), optimizing product lifecycle management (PLM), and streamlining manufacturing processes.
Solutions:
Oracle PLM Cloud: Implementation and validation of Oracle Product Lifecycle Management Cloud for design control, document management, and regulatory compliance.
GxP Validator: Automated validation for manufacturing equipment, software, and other GxP-regulated systems.
Quality Management Systems (QMS): Implementation and validation of QMS solutions to ensure compliance with FDA regulations.
Supply Chain & Manufacturing Optimization: Streamlining production processes and ensuring product traceability.
Risk Management: Implementing risk assessment and mitigation strategies.
We have the experience, knowledge, and flexibility to help you with business transformation, hybrid workplace strategy, technology implementation and adoption, and more.
Join the like minded community and get the latest updates and news on business, technology and digital to help improve your business.