Late Phase Pharmaceutical Drug Product Development
Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes suitable for late phase clinical trials, registration and ongoing commercial supply.
Our expertise covers the development of the following dosage forms:
- Immediate and modified release capsules
- Immediate and modified release tablets
- Fixed dose combination products
- Powder/granule filled sachets
- Multi-particulates (bead/pellets into capsules)
Our manufacturing technologies and processing scales range from hundreds of grams for small-scale process investigation studies to hundreds of kilograms for phase III/IV, registration batches and commercial supply.
We understand that the best way to ensure a smooth regulatory review process for an NDA or MAA is to clearly present a complete work package as defined through Quality by Design. By understanding the parameters that are critical to the quality of the product and the safety of the patient, we build quality into the product from the start, implementing effective control strategies.
With comprehensive dedicated drug product analytical testing laboratories we provide timely, quality data to not only support your regulatory submission but to aid critical business decisions regarding packaging, shelf life and supply chain to ensure your drug product reaches patients in optimum condition.