Our regulatory expertise extends to supporting IND, NDA, ANDA, DMF, and MA filings, ensuring a smooth pathway for global market access with comprehensive quality management systems.
At Shilpa Pharma Lifesciences Limited, we are dedicated to maintaining the highest levels of quality and compliance, ensuring that every product we develop meets and exceeds international regulatory expectations. Our comprehensive approach spans from development to manufacturing, with robust systems ensuring global market readiness.
State-of-the-art quality control laboratories with HPLC, UPLC, LC-MS, GC-MS, XRPD, and FTIR etc.
Analytical method development, validation, and transfer following ICH Q2 guidelines
Comprehensive stability studies under ICH Q1A(R2) conditions for global regulatory submissions
In-depth impurity profiling, elemental analysis, and microbiological testing capabilities
Preparation of Drug Master Files (DMFs), Common Technical Documents (CTD/eCTD), and Chemistry, Manufacturing & Controls (CMC) dossiers
Support for GMP audits, regulatory inspections, and customer quality assurance programs
Expertise in life-cycle management and post-approval regulatory compliance
Supporting IND, NDA, ANDA, DMF, and MA filings for smooth pathway to global markets
Contact Us today to learn more about our quality and regulatory capabilities!
