Spearheaded the development and rigorous validation of analytical methods for diverse pharmaceutical products, authoring comprehensive validation protocols and reports that ensured compliance with international regulatory standards.
Conducted critical pre-formulation studies and meticulously prepared stability and analytical protocols, significantly contributing to the robust development lifecycle and regulatory readiness of new drug products.
Streamlined the preparation of Standard Test Procedures (STPs) and managed the efficient transfer of initial raw data, stability data, and intermediate test samples, enhancing data integrity and operational workflow efficiency.
Compiled and prepared essential data for DGDA (Directorate General of Drug Administration) submissions and facilitated seamless technology transfer processes, ensuring regulatory adherence and efficient scale-up of pharmaceutical manufacturing.
Executed a wide range of analytical studies, including assay, dissolution rate, disintegration time, related substance, hardness, water content, and content uniformity across solid, liquid, and semi-solid dosage forms, directly impacting product quality and consistency.