AUSTAR provided R&D Compliance Consulting Services to a large listed and high-tech enterprise

With the expanding global diabetic population, demand for insulin and its analogs—cornerstones of diabetes management—continues to rise. Compared to conventional human insulin, insulin analogs offer optimized pharmacokinetic profiles and reduced hypoglycemia risks, thereby providing safer, more precise glycemic control. Their development and production demand advanced manufacturing technologies alongside strict adherence to global GMP standards and regulatory requirements, ensuring product quality and patient safety.

Project Background:

The client is a large listed company and a high-tech enterprise, primarily engaged in the research, development, production, and sales of insulin analog active pharmaceutical ingredients (APIs) and injectables. The client is committed to achieving comprehensive coverage of product lines in the field of diabetes diagnosis and treatment, further enhancing its market competitiveness in the diabetes treatment sector. While deepening its presence in the domestic market, the client continues to expand its global market, boosting its international brand influence, with products exported to more than ten countries worldwide.

AUSTAR Solutions:

AUSTAR offers CMC document review and consulting guidance.

AUSTAR Value and Client Benefits:

• The client's products have simultaneously initiated clinical trials in both China and the United States, complying with ICH guidelines, PDA technical reports, and WHO technical report requirements.

• AUSTAR's R&D compliance consulting services assisted the client in successfully completing clinical trials and regulatory submissions, fostering mutual growth between AUSTAR and the client's team.