Analytical method development refers to the process of creating and optimizing methods for the analysis of pharmaceutical compounds in various samples. These methods are essential for determining the identity, purity, content, and stability of drug substances and products. Validation, on the other hand, is the process of confirming that the analytical methods are suitable for their intended use and provide accurate and reliable results. Without proper methods in place, it would be impossible to monitor and control the quality of drug substances and products throughout the development process. In addition, analytical method development and validation also play a crucial role in meeting regulatory requirements and obtaining approval from regulatory agencies. Our company offers analytical method development and validation services for the biopharmaceutical industry. Our team of experts is dedicated to providing high-quality analytical methods customized to meet the unique needs of each client.
Our Expertise
- Our team's expertise extends across a wide range of pharmaceutical molecules and formulations, encompassing small molecules, biologics, nanoparticles, solids, patches, gels, ointments, liquids, and inhaled products. This diverse experience allows us to adapt our analytical methods to the unique characteristics and requirements of different drug types, ensuring that the methods developed are effective and reliable for a variety of pharmaceutical products.
- Our laboratories are equipped with sophisticated analytical technologies. These technologies include chromatography, mass spectrometry, elemental analysis, and spectroscopy, which provide accurate and precise results for the analysis of different drug components. By leveraging these advanced analytical tools, we can ensure the quality and integrity of the analytical data generated during the method development and validation stages.
- Our teams are proficient in a wide range of sample preparation techniques, including procedures tailored for trace level analysis and approaches suitable for the physical and chemical properties of the matrix and dosage form. The ability is critical in ensuring the accuracy and reliability of the analytical results obtained during method validation.
Our Analytical Method Development and Validation Platform
We offer comprehensive analytical method development and validation services tailored to the specific needs of each project. Our services include:
1Method Development
We meticulously evaluate attributes like precision, linearity, accuracy, and specificity during the development phase to guarantee that the method meets the criteria for validation.
2Method Optimization
We provide method optimization for diverse situations, such as enhancing critical peak separations, supporting formulation changes or in cases where methods have not been validated to current industry standards.
3Method Feasibility
In this respect, we familiarize the method, assessing attributes like precision, linearity, accuracy, and specificity to mitigate potential failures.
4Method Qualification
We conduct method qualification for supporting early-phase products to verify the appropriateness of the method for its intended use. This process may or may not be executed as per the protocol guidelines.
5Method Validation
For methods supporting later-stage products, we perform validation in accordance with the EP/USP general chapters and ICH guidelines. Validation is carried out under the strict guidance of a comprehensive protocol.
6Method Verification/Suitability
We undertake method verification/suitability on compendial methods to ensure their optimal performance on your API or product matrix. These procedures are meticulously executed under the guidance of a detailed protocol.
We provide analytical method development and validation services for:
- Potency, purity and dissolution analysis
- Cleaning validation analysis
- Excipients analysis
- Enantiomorphism isomers separation
- Stability study
- Residual/impurities testing
- Extractables and leachables testing
- Genotoxic impurities
- Microbial testing
- More
Our Advantages
There are several advantages to working with our team for analytical method development and validation.
- Firstly, we have a deep understanding of regulatory requirements and industry best practices, ensuring that our methods meet the highest standards of quality and compliance.
- Secondly, we have state-of-the-art facilities and equipment, allowing us to perform a wide range of analytical techniques with precision and accuracy.
- Finally, our team is committed to delivering results in a timely and efficient manner, helping to accelerate the drug development process and bring products to market faster.
Analytical method development and validation are essential components of drug development, ensuring the quality and safety of pharmaceutical products. Our expertise in this area can provide valuable support to your projects, helping to overcome challenges and achieve success in an increasingly competitive industry. Contact us today to learn more about how we can help with your Analytical Method Development and Validation needs.
It should be noted that our service is only used for research, not for clinical use.
