Systems Evaluation

standard-quality-control-collage-concept

Systems Evaluation

At Isha’s GMP Consultancy, we assist pharmaceutical and biotechnology companies in implementing Quality by Design (QbD) principles to ensure successful commercialization while maintaining regulatory compliance and operational efficiency.

Our Systems Evaluation Services Include:

  • Risk Management in R&D and Manufacturing
  • Evaluating process designs for efficiency and compliance
  • Developing and refining process control strategies
  • Implementing Process Analytical Technology (PAT) for real-time monitoring & control
  • Clinical Material GMP Compliance (Phases I, II, III)
  • Developing regulatory requirements for GMP compliance in clinical trial phases
  • Conducting audits and evaluations to ensure cGMP adherence
  • Development Practices Optimization
  • Assessing and streamlining product development to enhance efficiency and quality

Quality Control & Quality Assurance System Evaluation

  • Risk Assessment & Quality Systems Management
  • Identifying potential risks in quality systems
  • Implementing risk mitigation strategies for regulatory compliance
  • Quality Unit Optimization
  • Evaluating and enhancing roles and responsibilities of quality units
  • Ensuring alignment with FDA, EMA, and ICH regulatory expectations
  • Facilities, Equipment & Production System Assessment
  • Assessing and improving facilities and equipment systems
  • Enhancing materials management, production processes, and laboratory control systems

With Isha’s GMP Consultancy, your organization gains expert guidance to develop robust systems that drive regulatory success, operational efficiency, and product quality.

FDA Services