By providing end-to-end integrated services in a single location – including development, analytical testing, clinical packaging, and distribution alongside our core manufacturing capabilities – we minimise delays and streamline timelines for our clients.
Our capabilities are flexible, supporting projects from small-scale R&D through to commercial manufacturing, enabling smooth scale-up without disruption.
Our teams work closely with clients at every stage to ensure project goals are met efficiently and effectively. All services are delivered in a fully cGMP-compliant environment, ensuring regulatory compliance and consistently high-quality outcomes across development and manufacturing.
Our teams have the capability to support formulation and process development, working alongside clients to optimise manufacturing processes and accelerate timelines. These activities ensure innovations are practical, scalable, and aligned with regulatory requirements.
At IDT Australia, our Quality Control (QC) laboratories ensure every product – from intermediates and APIs to finished pharmaceuticals – meets the highest standards. Operating in a fully cGMP-compliant environment, our QC teams integrate analytical expertise and rigorous testing to support development, clinical, and commercial programs.
In-house testing for APIs and finished products, with tailored methods for small molecules and advanced therapies.
Environmental monitoring, bioburden, endotoxin, and sterility testing.
ICH-compliant studies to support shelf-life and regulatory submissions.
Smooth method handover, end-to-end testing, and documentation to accelerate clinical and commercial timelines.
Our Quality Assurance (QA) teams provide integrated oversight across all stages of development, tech transfer, and manufacturing, ensuring consistent compliance and high standards.
Rigorous Oversight: Our dedicated quality teams oversee every stage of development, tech transfer, and manufacturing, safeguarding the integrity, purity, and efficacy of each product.
Comprehensive Documentation: All processes are thoroughly documented, supporting traceability, regulatory compliance, and audit readiness.
Continuous Improvement: We maintain a culture of quality, constantly refining processes, technologies, and systems to exceed client and regulatory expectations.
Reliable logistics solutions ensure your product reaches its destination safely and on schedule. Our distribution network supports both local and international delivery, providing peace of mind for our clients.
In addition, we offer comprehensive supply chain management, including:
Monitoring and managing raw materials and finished goods to maintain uninterrupted supply.
Handling temperature-sensitive products to preserve quality and stability.
Ensuring all transportation and handling meet local and international regulatory requirements.
Providing full visibility of products throughout the supply chain.
We provide end-to-end product readiness, including customised labelling and packaging solutions to ensure compliance and market readiness. Our capabilities extend to clinical trial support, including:
Dedicated project management teams coordinate every step of the process, from development to delivery, providing clear communication, timelines, and milestones to guarantee seamless execution.
Coordination of internal and external resources to ensure seamless project execution.
While we do not provide regulatory affairs services, our experts can provide practical guidance to support compliance across manufacturing, analytical, and packaging activities. This includes support for regulatory submissions and documentation, particularly where it intersects with development and quality:
Streamline your drugs manufacturing journey with complete CDMO solutions at IDT Australia
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