Quality Assurance and Control

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Quality Assurance and Control

At Isha’s GMP Consultancy, we leverage our extensive industry expertise to provide comprehensive Quality Assurance (QA) and Quality Control (QC) solutions for pharmaceutical, biotechnology, and healthcare companies.

Our QA & QC Services Include:

  • Evaluation of Written Procedures & SOPs
  • Reviewing and refining Standard Operating Procedures (SOPs) to align with regulatory requirements
  • Ensuring compliance with FDA, EMA, WHO, and ICH guidelines
  • Regulatory Interpretation & Compliance
  • Interpreting complex regulations in line with industry best practices
  • Providing expert guidance to meet current FDA expectations
  • Analytical & Laboratory Quality Services
  • Developing laboratory quality systems
  • Designing analytical methods and validation strategies
  • Defining product component specifications
  • Self-Evaluation & Continuous Improvement
  • Consulting on self-evaluations to assess compliance gaps
  • Creating sampling plans and trend analysis reports
  • Corporate Oversight & Governance Enhancement
  • Implementing corporate quality compliance functions
  • Providing independent advisory services to CEOs, senior managers, and board members
  • Site Oversight & Internal Audits
  • Conducting internal audits and performance assessments
  • Reviewing and enhancing management controls for compliance sustainability
  • Organizational Structure & Competency Review
  • Optimizing functions, reporting relationships, and staffing
  • Strengthening communication systems to improve vertical and horizontal coordination
  • Ensuring independence, staffing, and competence of quality teams

With Isha’s GMP Consultancy, you gain a trusted partner in building robust Quality Assurance & Control systems that drive regulatory success and operational excellence.

FDA Services