Method Transfer Services & Method Optimization Services

With expertise in custom synthesis, analytical services, and drug development.
We are here to support all your research needs by reducing the project timeline and cost.

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Our Partners:

Inbound Method Transfer

We specialize in transferring methods from our clients or external laboratories to our facility. Our method transfer process includes:

ARSI Canada
Method Evaluation

Assessing the suitability of the method for transfer, considering factors such as complexity, robustness, and regulatory requirements.

ARSI Canada
Method Optimization

Optimizing the method if necessary to ensure robustness, accuracy, and efficiency.

ARSI Canada
Method Validation

Validating the transferred method to ensure it meets regulatory standards and performs reliably in our laboratory.

Outbound Method Transfer

We also transfer validated methods developed at ARSI to our clients or external laboratories. Our outbound method transfer process includes:

ARSI Canada
Comprehensive Documentation

Providing detailed transfer protocols, validation reports, and method SOPs to support successful method implementation.

ARSI Canada
Training and Support

Offering training and technical support to ensure effective method transfer and implementation at the receiving laboratory.

Robustness Testing

We conduct robustness testing to evaluate the robustness of analytical methods and identify critical parameters that may affect method performance. Our robustness testing includes:

ARSI Canada
System Suitability Testing

Assessing system suitability parameters such as resolution, tailing factor, and retention time.

ARSI Canada
Forced Degradation Studies

Subjecting samples to stress conditions to evaluate method robustness and identify potential degradation products.

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Why ARSI Canada Inc.?

Choosing ARSI Canada Inc. for your method transfer and optimization needs means partnering with a team dedicated to delivering excellence. Our robust transfer and optimization processes, regulatory expertise, and commitment to quality ensure that your analytical methods are reliable, efficient, and compliant with regulatory standards.

Get in touch with ARSI Canada Inc. for comprehensive method transfer and optimization services and ensure seamless method transfer, improved method performance, and regulatory compliance.

FAQs about Method Transfer and Optimization at ARSI Canada Inc.

What is method transfer in analytical chemistry?

Method transfer in analytical chemistry involves transferring analytical methods from one laboratory to another while ensuring that the method performs reliably and consistently in the receiving laboratory.

Why is method transfer important in pharmaceutical analysis?

Method transfer is important in pharmaceutical analysis because it allows pharmaceutical companies to replicate and implement validated methods across different laboratories, ensuring consistency, reliability, and regulatory compliance.

What is method optimization, and why is it necessary?

Method optimization involves improving the performance, efficiency, and robustness of existing analytical methods. It is necessary to enhance method sensitivity, reduce analysis time, and meet evolving project needs and regulatory standards.

How does ARSI ensure the successful transfer of analytical methods?

ARSI ensures the successful transfer of analytical methods through a systematic approach that includes method evaluation, optimization, validation, comprehensive documentation, and training and support for the receiving laboratory.

What types of method optimization services does ARSI offer?

ARSI offers a wide range of method optimization services, including robustness testing, parameter optimization (such as column and mobile phase selection, gradient optimization, and detector settings optimization), and forced degradation studies.

Can ARSI optimize methods developed by other laboratories?

Yes, ARSI can optimize methods developed by other laboratories to improve their performance, sensitivity, and efficiency. Our optimization services are tailored to meet the specific needs of each client and project.

How long does method transfer and optimization typically take?

The duration of method transfer and optimization varies depending on the complexity of the method and specific project requirements. Typically, it can take several weeks to a few months. ARSI works closely with clients to provide accurate timelines and ensure timely completion of projects.

What documentation is provided after method transfer and optimization?

After method transfer and optimization, ARSI provides comprehensive documentation, including transfer protocols, validation reports, method SOPs, and optimization reports. This documentation supports regulatory submissions and quality assurance processes.

How does ARSI ensure regulatory compliance in method transfer and optimization?

ARSI ensures regulatory compliance in method transfer and optimization by adhering to guidelines set by regulatory agencies such as the FDA, EMA, and ICH. Our transfer and optimization processes are designed to meet global regulatory standards.

Can ARSI provide training and support for method transfer and implementation?

Yes, ARSI offers training and technical support to ensure effective method transfer and implementation at the receiving laboratory. Our experts provide hands-on training and guidance to ensure successful method implementation.

Discuss your drug discovery & development needs, get a custom quote today!