Callidus Research Laboratories is a leading provider of comprehensive pharmaceutical analytical development services. We are committed to partnering with pharmaceutical companies to ensure the quality, safety, and efficacy of their drug products. Our state-of-the-art laboratory, staffed with a team of skilled scientists and equipped with cutting-edge instrumentation, enables us to deliver precise and reliable analytical solutions tailored to your specific needs. At Callidus, our world-class analytical expertise empowers you to navigate the complexities of drug development with confidence
Our Analytical Development Services encompass a wide range of offerings, including but not limited to:
API Characterization:
We provide in-depth analysis and characterization of Active Pharmaceutical Ingredients (APIs), ensuring their purity, identity, and quality. The thorough analysis of Active Pharmaceutical Ingredients (APIs) helps to understand their molecular properties and characteristics, laying the foundation for successful formulation.
Solubility Profiling of API:
Our experts conduct solubility studies to assess the API's solubility in various buffers and non-aqueous solvents, crucial for formulation development to optimize bioavailability and enhance formulation performance.
API Forced Degradation Studies:
Through forced degradation studies, we evaluate the stability and degradation pathways of APIs, enabling you to optimize product formulations. By assessing the stability of APIs under different stress conditions we help in predicting degradation pathways to ensure product integrity.
Compatibility Testing of API and Excipients:
We conduct comprehensive compatibility testing of APIs with excipients, ensuring compatibility and stability during the formulation process ensuring product safety
Innovator Product Characterization:
We conduct thorough studies to reverse engineer the innovator product by employing advanced analytical techniques allowing for comparative analysis and potential product development with improved product understanding.
Analytical Method Development of API and finished dosage forms: Our team designs precise and robust analytical methods for drug substances and drug products, meeting specific product needs while adhering to regulatory/ICH requirements.
Stability Studies:
Following ICH guidelines, we conduct comprehensive stability studies including photo stability studies to assess the shelf life and storage conditions of your pharmaceutical products and define stringent specifications to guarantee product quality and consistency that is crucial for regulatory compliance and market success.
Pharmaceutical Equivalence Studies:
We perform multimedia dissolution and equivalence studies to support dossier extension and generic product development
Method Validation and Transfer:
We perform method validation in line with regulatory/ICH requirements and facilitate seamless method transfer to manufacturing sites ensuring accurate and consistent results,
Cleaning Method Development: Our experts develop and validate cleaning methods to support manufacturing sites, ensuring product safety and compliance.
Identification & Quantification of Impurities and Degradants: We help customers precisely detect quantify and controlling impurities, contaminants, and degradants in drug products ensuring the safety of all medicines developed by us.
Regulatory Support:
Our team provides regulatory support throughout the drug development process, ensuring compliance with relevant guidelines and guaranteeing smooth approval processes.
At Callidus Research Laboratories, we offer complete, reliable and timely analytical support for dossier filing and regulatory submissions. Our commitment to excellence and client satisfaction drives us to deliver exceptional results that accelerate your drug development success. Partner with us to experience unparalleled analytical expertise and support tailored to your unique needs.
Whether you require standalone analytical services or complete support for your drug development journey, we are here to guide you every step of the way.
Contact us today to embark on a journey of innovation and quality in pharmaceutical development.