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Research Consultancy
TruProbe Consultancy Company, leveraging its profound expertise in laboratory design and setup, along with accreditation and validation processes, can offer a comprehensive suite of services under its Research Consultancy module. These services are designed to support organizations in achieving operational excellence, compliance with international standards, and successful product development.
Laboratory Design and Setup
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- Customized laboratory design planning to meet client-specific needs.
- Guidance on equipment selection and procurement to optimize laboratory operations.
- Implementation of best practices for laboratory workflow to enhance efficiency and safety.
Laboratory Accreditation Assistance
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- Consultation on achieving accreditation for various standards such as NABL (National Accreditation Board for Testing and Calibration Laboratories), CAP (College of American Pathologists), and CLIA (Clinical Laboratory Improvement Amendments).
- Preparation of documentation and assistance in the implementation of quality management systems to meet accreditation requirements.
- Mock audits and gap analysis to identify and rectify non-conformities before the actual accreditation audit.
Assay Optimization and Validation
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- Development and optimization of assays for enhanced performance and reliability.
- Validation of assays according to international guidelines to ensure accuracy, precision, specificity, and sensitivity.
- Support in the transition of assays from research to clinical use.
In Vitro Diagnostic (IVD) Kit and Medical Device Development
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- End-to-end support in the development of IVD kits and medical devices, from concept to commercialization.
- Assistance in prototype design, development, and testing to ensure product efficacy and safety.
- Validation services to demonstrate product performance in line with regulatory standards.
Clinical Validation Studies
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- Design and execution of clinical validation studies to support the efficacy and safety of medical products.
- Statistical analysis of study data to derive meaningful conclusions.
- Preparation of study reports and documentation to support regulatory submissions.
Regulatory Documents Preparation and Submission
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- Comprehensive support in preparing and compiling regulatory documents for submissions to regulatory bodies such as FDA, EMA, and other national health authorities.
- Strategic advice on regulatory pathways and compliance requirements for market access.
- Assistance in responding to regulatory queries and managing communications with regulatory agencies.
Quality Control and Assurance
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- Development of quality control protocols to ensure product consistency and compliance with standards.
- Implementation of quality assurance practices to monitor and improve the quality of laboratory operations and product development processes.
Training and Development
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- Customized training programs for laboratory personnel on best practices, operational excellence, and compliance with accreditation standards.
- Workshops and seminars on the latest technologies and methodologies in laboratory research and product development.
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