Oral Finished Dose

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Leading the Way in the Development and Manufacturing of Oral Finished Doses

As a distinguished leader in the development and manufacturing of oral finished doses, IDT is at the forefront of the pharmaceutical industry. With our extensive capabilities, we excel in the conversion of in-house produced APIs and the seamless tech transfer of products developed in collaboration with formulation houses.

As a specialist manufacturer of finished dose forms, we provide comprehensive support for pre-clinical and clinical studies ranging from Phase I to Phase III, as well as commercial supply. Our expertise extends to solid dose oral forms as well as liquid dose oral forms, facilitated by our state-of-the-art facilities equipped to handle high potency and high containment requirements.

As a trusted CDMO, IDT prioritises exceptional quality and regulatory compliance in oral finished dose manufacturing. Through strong collaboration with MMIC, we deliver innovative pharmaceutical solutions, exceeding client expectations and advancing healthcare outcomes.

Leading the Way in the Development and Manufacturing of Oral Finished Doses

IDT specialises in the bespoke manufacture of solid dosage forms tailored to meet the specific needs of clinical batches from Phase I to Phase III. With extensive experience in manufacturing clinical materials, IDT excels in supporting fully blinded studies. Our capabilities set us apart in several key aspects:

On-Site Support: IDT provides comprehensive on-site support for the manufacturing process, including the manufacture, chemistry, and microbiological testing of finished products, as well as stability studies.
Streamlined Processes: We eliminate the challenges associated with multiple tech transfers by handling product transitions within the same expert team. This streamlined approach ensures efficiency, consistency and minimises delays.
Expertise and Quality Assurance: IDT's team of experts possess extensive knowledge and expertise in manufacturing solid dosage forms, allowing for precise execution of clinical batches. Our robust quality system ensures that all products meet stringent standards and regulatory compliance.

At IDT, we are committed to delivering exceptional services that support the development and manufacturing of oral finished doses. Our integrated approach and dedication to quality assurance guarantee reliable results and accelerate the progress of clinical studies.

Regulatory Compliance

IDT operates as a reputable pharmaceutical manufacturer in a strictly regulated cGMP environment, with a focus on the development and manufacturing of oral finished doses. Our facility has successfully undergone comprehensive audits and received accreditation from established regulatory authorities, including the Australian Therapeutic Goods Administration, the U.S. Food and Drug Administration, and the Japanese Ministry for Health Labour and Welfare.

Additionally, our commitment to upholding high-quality GMP standards extends to Europe and Canada through The Mutual Recognition Agreement. These certifications validate our dedication to adhering to stringent quality control measures and complying with international regulatory requirements specific to the development and manufacture of oral finished doses.

End to End Product Development

As a leading pharmaceutical CDMO, IDT excels in developing and manufacturing oral finished doses. With expertise in optimising APIs and large-scale production of finished dosage forms, we provide comprehensive end-to-end services for investigational medicinal products.

Our extensive experience, technical proficiency, and scalable capabilities make us the ideal partner for your oral finished dose projects. From research and development to manufacturing investigational APIs and finished dosage forms for clinical trials, our seamless support is provided within a single site, under a unified quality system.

IDT’s end-to-end services ensure efficient and reliable outcomes, showcasing our commitment to excellence in oral finished dose development and manufacturing.

In-House Method Development

Our in-house method development capabilities for oral finished doses enhance efficiency and reduce project timelines. This integrated approach ensures method suitability prior to validation, benefiting later-stage clinical projects.

As IDT operates within a complete cGMP environment we ensure adherence to rigorous quality and regulatory standards. Our internally integrated analytical services allow us to streamline manufacturing processes and deliver a seamless experience to our clients.

This comprehensive approach eliminates the necessity for external tech transfers, allowing us to maintain control over the entire development process. The outcome is exceptional quality and diminished complexities for our clients in the realm of oral finished dose development and manufacturing.

Quality by Design

At IDT, we are committed to meeting our clients' needs as a pharmaceutical CDMO by delivering high-quality oral finished doses. Our development program and Tech Transfer process are grounded in Quality by Design (QbD) principles, ensuring the fulfillment of a Quality Target Product Profile (QTPP).

This approach prioritises efficient experimental design and employs risk management strategies, resulting in optimised APIs and finished dosage forms that exceed product specifications. Our program expedites the product development and registration process through the generation of submission-ready data and documents.

Recognising the importance of speed to market, we uphold our dedication to delivering prompt and efficient products that meet the highest quality standards. With our QbD program, we provide our clients with an exceptional experience, consistently delivering oral finished doses that align with their needs and expectations.

Strong Global Network Specialising in API Development

As a trusted CDMO, IDT prioritises rapid drug formulation, process optimisation, and minimising trial delays in the development and manufacture of oral finished doses. To achieve these goals, we foster strong collaborations with product development specialists in Melbourne and across the globe, granting us access to advanced research, development expertise, and state-of-the-art tools.

We efficiently optimise process chemistry and drug product formulations through these collaborations, minimising delays and accelerating product development. This is achieved by leveraging international expertise and minimising trial-and-error experimentation. Our collaborative approach ensures the best possible outcomes for our clients in the field of oral finished dose development and manufacturing.

Full-Spectrum API Manufacturer (CDMO)

As a specialised pharmaceutical manufacturer, IDT excels in the manufacture, chemistry, and microbiological testing of oral finished products. With on-site support and a unified quality system, we ensure seamless coordination throughout the entire development process. Our dedicated team of experts handles product transitions from manufacture through analysis and release, eliminating the complexities of multiple tech transfers.

IDT is well positioned to address the increasing demand for oral finished doses, particularly in combination therapies across various therapeutic areas. Our unique advantages include:

HPAPI Specialisation: Efficient access to key compounds for oral finished doses across therapeutic areas.
Full Support: End-to-end services from research to market launch, ensuring seamless coordination.
Oral Dose Expertise: Strong capabilities in developing innovative oral finished doses.

Leveraging our specialised capabilities, researchers and pharmaceutical companies can accelerate oral finished dose development, offering effective treatments across a wide range of therapeutic areas.

Contact IDT Australia

If you’re looking for quality, turnkey cGMP contract manufacturing services, please get in touch with us today.