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Scientific and Technical Assistance
Scientific and Technical Assistance
At Isha’s GMP Consultancy, our scientific and technical experts bring decades of real-world industry experience to provide accurate, actionable recommendations for compliance and regulatory challenges.
Our Scientific & Technical Services Include:
- Laboratory Controls & Investigations
- Developing and enhancing laboratory control systems
- Performing laboratory investigations to resolve deviations and non-conformities
- Bioequivalence & Bioanalytical Assessment
- Â Assessing bioequivalence studies for regulatory approval
- Evaluating the adequacy of bioanalytical methods and laboratories
- Product Development & Stability Assessment
- Optimizing product formulations and processes to improve quality & efficacy
- Assessing product stability under various conditions to ensure shelf-life compliance
- Process Optimization & Analytical Technology
- Evaluating process designs for efficiency and compliance
- Developing and refining process control strategies
- Implementing Process Analytical Technology (PAT) for real-time monitoring & control
- Analytical Method Development & Specification Setting
- Developing analytical methods in compliance with ICH, FDA, and EMA standards
- Defining and setting product specifications to ensure quality consistency
With Isha’s GMP Consultancy, you gain access to specialized scientific and technical expertise that helps you achieve regulatory success, optimize operations, and enhance product quality.