Shilpa Pharma Lifesciences Limited (SPLL) offers wide range of analytical chemistry services and offers best results with minimal timelines. These services could be either integrated with CDMO project or stand-alone project. Proven scientific capabilities, periodical communication and providing requisite data will be helpful to compile CMC documentation as required to support regulatory filings (IND/NDA) of our customers.
Shilpa Pharma has well qualified scientists and technical leaders who are dedicated in understanding analytical problem / requirements, deriving analytical solutions and serving our customers effectively.
Structure elucidation of new chemical entities (NCE’s), impurities, degradation products, metabolites and other compounds by various spectroscopic techniques such as IR, UV-Visible, NMR, mass spectroscopy and others.
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
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.
