Scale Up and Late Stage Development, Scale up, late stage development, immediate release, modified release, controlled release, DoE, Design of experiment, Quality by design, QbD

Scale Up and Late Stage Development

We have the necessary experience to develop robust formulations and manufacturing processes which will enable confidence and security in the supply chain.  We have assisted many of our clients in developing both immediate and modified release formulations for their late stage clinical trials, registration batch manufacture and commercial launch.

We understand that the best way of ensuring a smooth regulatory review process for an NDA or MAA is to clearly present the results from a well defined series of experiments that demonstrates a thorough understanding of the formulation and the manufacturing process.  By understanding those parameters which are critical to the quality of the product and ultimately the safety of the patient, we are able to build quality into the product from the start and are also able to implement effective control strategies around parameters which are shown to be most critical.

Almac Advantage

Scientific Continuity

Integrating your development requirements through to commercialisation, our technical and supply teams work seamlessly to ensure your requirements are delivered.

Quality

Supplying products and services globally, we have been successfully inspected by the MHRA, FDA, ANVISA and other regulatory authorities, ensuring the highest quality standards.

Experience

We have been developing and manufacturing solid oral dose products for more than 30 years.

Commercial Scale Up

Designed to ensure our development manufacturing technology, including ‘transfer of information’ is scalable to our commercial processes provides our clients a smooth transition to commercial volumes

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