Early Stage Development, Formulation development, First in Man, First in Human, Xcelodose, Phase I, Rapidd, API in capsule, API in bottle

Early Stage Development

Our formulation scientists have many years’ experience in developing a range of oral dose formulations for early stage clinical trials.

For early phase, First–in-Human (FIH) supplies, we offer a range of solutions:

We can quickly fill small quantities of capsules by hand or using capsule boards. We also have automated technology such as the Xcelodose® 600S precision powder micro-dosing system.

The most common approach for early development is to develop a relatively simple formulation using common pharmaceutical excipients.  We believe in Quality-by-Design (QbD) therefore when we develop blending, roller compaction or granulation processes we always keep an eye to the future to ensure that your formulation can be scaled up for later stage clinical supply.

Almac Advantage

Potent Capabilities

Utilising bespoke high containment suites, we can assist you in developing and manufacturing highly potent products. Click here to find out more.

Project Management

Acting as your representative on site, our Project Managers are experienced pharmaceutical professionals committed to delivering your objectives by building strong relationships with you. Your dedicated Project Manager, from project initiation to conclusion, will deliver agreed objectives to plan and budget.

Scientific Continuity

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

Accelerated First-in-Human Service – Rapidd

Rapidd™ offers a complete set of solutions aimed at accelerating entry into early stage clinical development. Rapidd™ is a lean, efficient, integrated solution from selection of pre-clinical candidate to Phase I regulatory submission.

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