Analytical Method Development
At Cubic Analytical Solution, we specialize in providing robust Analytical Method Development services to support the pharmaceutical, cosmetic, and food industries. Our method development services are designed to deliver reliable and precise analytical techniques that ensure your products meet quality, safety, and regulatory standards at every stage of production.
Tailored Solutions in Analytical Method Development
Customized Analytical Method Development
We offer customized method development tailored to your specific product needs. Our experienced team designs and optimizes analytical methods for a variety of applications, including quantification of active ingredients, impurity profiling, and identification of degradation products.
Method Validation
Once developed, our methods undergo rigorous validation in line with regulatory guidelines from the FDA, ICH, and other global authorities. This process ensures our methods are reliable, sensitive, specific, and reproducible, covering key parameters like accuracy, precision, linearity, limit of detection (LOD), and robustness.
Importance of Analytical Method Development
Robust analytical methods are essential for ensuring quality, safety, and efficacy of products. In pharmaceuticals, method development is critical for analyzing formulations, detecting impurities, and validating stability. In cosmetics and food, these methods ensure compliance and maintain consistency.
Tailored Solutions for Your Needs
At Cubicana, we work closely with your team to understand the specific challenges of your product and manufacturing process. Whether you need methods for raw material testing, in-process controls, or finished product analysis, we provide flexible solutions that align with your business objectives.
Regulatory Compliance Support
Navigating regulatory requirements is essential for market approval. Our methods are developed and validated to meet strict standards of international authorities, including FDA, EMA, and ICH guidelines. We assist in preparing documentation for submissions, ensuring smooth product approval.
Expert Consultation and Support
Our expert consultation services are available to guide you through every step of the method development and validation process. We offer insights on how to optimize your methods for accuracy and efficiency and provide training to ensure your team understands the analytical techniques involved.
Why Choose Us?
With our extensive experience in analytical method development, Cubicana is committed to delivering customized, reliable, and regulatory-compliant methods that meet your exact requirements. We combine industry-leading technology with a focus on client satisfaction to provide services that enhance the quality and success of your products.