Method Development and Validation

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Product Details:

Material All Types / Laboratory Grade
Size Customised
Frequency 50/60 Hz
Display Digital
Driven Type Electronic
Temperature Ambient / As Required
Power As per Instrument
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Method Development and Validation Price And Quantity

Minimum Order Quantity 1

Method Development and Validation Product Specifications

Usage & Applications Pharmaceutical, Analytical & Clinical Laboratories
Voltage 220-240 V AC
Weight According to Equipment
Interface User Friendly Software Interface
Measuring Range Varies as per Method & Equipment
Material All Types / Laboratory Grade
Size Customised
Frequency 50/60 Hz
Display Digital
Driven Type Electronic
Power As per Instrument
Temperature Ambient / As Required

Product Description

We provide research support in Method development for various bio-actives.
As Natural Feedstocks are abundant in various bio-actives like minerals, hormones, polysaccharides, osmolytes, proteins and hormones. Analysis of interest of active requires extensive research and expertise to select suitable method development. Our scientific team is experts in selection of method, verification and validation.
Method Verification and validations are performed as per international standards.

Method validation Covers:

1. Extraction of molecule of interest
2. Linearity & Range
3. Accuracy & Recovery,
4. Limit of detection & quantification,
5. Precision- repeatability,
6. Robustness,
7. Measurement uncertainty.
8. System Suitability

which has made us capable to understand the synergy & quantify minute quantities of actives.

Precision and Compliance Assured

Our methodology rigorously follows standard protocols required by ICH, FDA, and GLP. Each process is tailored to deliver high accuracy, precision, and specificity, ensuring all validated methods meet regulatory standards. Custom reports detail every validation parameter, supporting clear regulatory submissions and audits.

Versatile Instrument Compatibility

Fully compatible with leading laboratory instruments, including HPLC, GC, UV, IR, and dissolution systems, our services flexibly adapt to existing setups. Whether your equipment is laboratory grade or customized, our approach maintains optimal functionality and integrity while accommodating a variety of method types.

Comprehensive Documentation & User-Friendly Experience

Each project is meticulously documented, from development through validation, offering complete traceability and robust support for regulatory review. User-friendly software interfaces and optional automation enhance workflow efficiency, making method execution and reporting simple and intuitive even for complex requirements.

FAQ's of Method Development and Validation:

Q: How does your method development comply with regulatory standards such as ICH, FDA, and GLP guidelines?

A: We follow globally recognized protocols and standards mandated by ICH, FDA, and GLP, ensuring all validation activities are fully compliant. Our validation reports incorporate detailed documentation on accuracy, precision, specificity, linearity, robustness, and range, meeting all regulatory submission requirements.

Q: What instruments are compatible with your method development and validation services?

A: Our services are compatible with HPLC, GC, UV, IR, dissolution, and other laboratory instruments. Whether you use standard laboratory-grade equipment or customized setups, we tailor our approach to your specific needs.

Q: When is comprehensive documentation provided during the validation process?

A: Comprehensive documentation is prepared at every stage, from initial method development to final validation. Clients receive full reports at project completion, including all test parameters, data analysis, and compliance statements, to support regulatory and internal reviews.

Q: Where can your method development and validation services be applied?

A: Our solutions are designed for use in pharmaceutical, analytical, and clinical laboratories. We adapt to diverse laboratory environments across India, ensuring seamless integration with your existing workflows and equipment.

Q: What are the benefits of using a user-friendly software interface for method validation?

A: The intuitive interface streamlines method setup, execution, and reporting processes. This reduces user errors, accelerates workflow, simplifies data management, and enhances overall efficiency, making it accessible for both new and experienced laboratory personnel.

Q: How is the measuring range and power requirement determined for each method?

A: Measuring range and power specifications are adapted to the method type and selected equipment. We assess each project individually to optimize compatibility, ensuring accurate results and reliable instrument performance throughout your validation.

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