CD Formulation provides robust analytical method development and validation testing services for your drug development projects, including but not limited to raw materials, excipients, API, and finished products, to ensure that your drugs comply with regulatory requirements and meet the required quality standards. Our professional team with extensive experience and expertise can tailor an analysis solution that suits your project needs and provide accurate and reliable results and solutions.
Analytical method development and testing, a critical step in drug product development, involves the creation of a standard and robust set of experimental conditions to perform analytical and testing procedures for target ingredients. The developed analytical methods can be used to identify, separate, and quantify chemical components used in commercialized pharmaceutical products. For drug development companies, it is essential to understand the physical and chemical properties of the drugs being produced, which can ensure drug candidates successfully undergo pre-formulation, formulation, and commercial production processes, resulting in ensuring drug quality and compliance with regulatory requirements.
Thanks to our decades of experience in analytical methods developing and validating our customers, CD Formulation can provide you with accurate, low-limit-of-qualification (LOQ) methods for your small and large-molecule drugs. Whether you are bringing a new product to market or analyzing existing products for impurities and residual solvents, we can provide you with a full range of services. Importantly, our laboratories are equipped with state-of-the-art instrumentation to meet a variety of testing requirements, and our team of experts continuously evaluates and expands our testing capabilities to meet the growing needs of our customers. Our services include but are not limited to:
We provide UPLC/HPLC analytical method development and optimization services for each of your products, including precision (repeatability and intermediate precision), accuracy, detection limit, quantification limit, etc.
Our analytical method validation, verification and transfer services include evaluating the performance characteristics of the method, such as accuracy, precision, specificity, limit of detection, and linearity, and ensuring that the method meets the necessary requirements for its intended application.
We screen, test, and characterize APIs and excipients for you to ensure your pharmaceuticals are delivered promptly and efficiently.
We offer a full suite of analytical techniques to evaluate your APIs and pharmaceutical products, including but not limited to ICH stability testing, dissolution and disintegration testing, moisture analysis, extractable and leachable analysis, impurities and residual solvent analysis, viscosity analysis, etc.
We provide Q1/Q2 (Q3) pharmaceutical deformulation and reverse engineering services to help you identify and analyze the composition of your competitor's products to accelerate your generic drug development.
CD Formulation analytical team specializes in providing regulatory-compliant analytical methods for the development and testing of small molecules, large molecules, and generic drugs. Our expertise includes:
CD Formulation's mission is to provide specialized analytical method development and testing services to streamline your drug development program, save you time and money, and accelerate time to market. Whether you need assistance with method development, validation, impurity profiling, or stability testing, we are here to support your project every step of the way. Please contact us today to see how we can help you achieve your development goals.
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