Austar, a Hong Kong-based provider of integrated cleanroom and pharmaceutical engineering solutions, has completed a research and development (R&D) compliance consulting project for a major listed, high-tech enterprise specialising in insulin analogues.
The project supports the client’s ongoing efforts to enhance its global competitiveness in the diabetes treatment sector.
The client, a large listed company with a primary focus on the research, development, production, and sales of insulin analogue active pharmaceutical ingredients (APIs) and injectables, has positioned itself as a key player in diabetes care.
In this collaboration, Austar provided specialised R&D compliance consulting services
The company is actively expanding its global footprint, with products exported to over ten countries, while simultaneously consolidating its presence in the domestic market.
Its commitment to offering a comprehensive portfolio in diabetes diagnosis and treatment continues to drive its growth and market influence.
In this collaboration, Austar provided specialised R&D compliance consulting services, including the review of CMC documents and strategic guidance to ensure alignment with international regulatory frameworks.
The project enabled the client’s products to initiate clinical trials concurrently in China and the United States
The project enabled the client’s products to initiate clinical trials concurrently in China and the US, adhering to the International Council for Harmonisation (ICH) guidelines, Parenteral Drug Association (PDA) technical reports, and World Health Organization (WHO) technical requirements.
This initiative highlights Austar’s capability to support high-tech pharmaceutical enterprises through complex regulatory landscapes, contributing to successful clinical trials and regulatory submissions.
The partnership underscores both organisations’ shared commitment to upholding the highest standards in pharmaceutical manufacturing and patient safety.
