At Shilpa Pharma Lifesciences Limited (SPLL), we deliver comprehensive analytical method development and validation services to support your product’s quality, safety, and regulatory compliance throughout its lifecycle.
Our team of experienced scientists and analysts provides customized analytical development services that include method creation, optimization, and validation for both small and large molecules. These services are essential for compiling accurate CMC documentation and facilitating smooth regulatory filings (IND/NDA).
Whether integrated within a CDMO project or as a standalone analytical service, our offerings ensure robust and reproducible results aligned with international standards.
Structure elucidation is essential in pharmaceutical development for determining the exact molecular structure of compounds such as new chemical entities (NCEs), impurities, degradation products, and metabolites. At Shilpa Pharma, we use a range of advanced spectroscopic techniques—including NMR, mass spectrometry, IR, and UV-Visible spectroscopy—to accurately identify and confirm chemical structures. This supports product development, impurity profiling, and overall compound characterization.
These services play a critical role in ensuring product quality and regulatory readiness. By integrating structure elucidation with our broader analytical development services, we provide clear, reliable data to support method development, impurity evaluation, and compliance with global standards. Our work is carried out in a fully equipped analytical testing laboratory, helping accelerate CMC timelines while ensuring scientific accuracy and data integrity.
Analytical method development of HPLC & GC methods for raw material, intermediates and NCE/API
Analytical method development and validation of detoxification / decomposition of Oncology APIs
Analytical method validation studies as per ICH and ANVISA guidelines for raw material, intermediates and NCE/API
Cleaning method development for intermediate and APIs
Forced degradation studies to showcase the specificity of stability indicating methods and gather essential data for determination of proper storage conditions, packaging and shelf life of product, which are vital for regulatory documentation
Establishing degradation pathways of drug substances
Revealing degradation mechanisms such as hydrolysis, oxidation, thermolysis or photolysis
Establishing degradation pathways of drug substances
Establishing the stability-indicating nature of a developed method
Understanding the chemical properties of drug molecules
Creating a degradation profile similar to formal stability studies under ICH conditions
Ensuring that a method developed in a client’s lab functions effectively at our lab, and vice versa, is crucial for maintaining consistency and meeting regulatory requirements. We focus on preserving precision throughout the entire life cycle of the API to ensure that the method is reliable, reproducible, and consistent across different laboratories or facilities.
Review the method and its development history (e.g., method validation results, data from the original lab).
Create a detailed AMT protocol outlining the transfer objectives, acceptance criteria, timeline, and test conditions.
Ensure that the receiving lab is equipped with the same or equivalent equipment to guarantee a seamless and effective process.
A detailed report documenting the method transfer process, including the results, deviations, and any corrective actions taken.
At Shilpa Pharma, our comprehensive analytical method development and validation services in India are delivered through a state-of-the-art chemical testing and analytical laboratory. We combine scientific expertise with advanced analytical testing techniques to provide reliable, regulatory-compliant results. Our team supports every stage of analytical method validation, analytical process validation, and analytical method verification, ensuring your projects meet global quality standards. Partner with us for efficient, scalable, and customized analytical development services tailored to your specific needs.
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