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Active Pharmaceutical Ingredient (API) Clinical Development

Bespoke Active Pharmaceutical Ingredient Development

We pride ourselves on being flexible and tailoring our active pharmaceutical ingredient (API) development services to meet each project’s requirements. Since we work on a diverse range of compounds, our capabilities are not limited to any particular therapeutic area, which enables us to quickly implement new work programmes to achieve customer objectives.

active pharmaceutical ingredient development

Process Development Focusing on Safety and High-quality

From route scouting and column screening to process and analytical development we offer tailored API development services focusing on quality safety and efficiency.

We take a QbD approach to process and analytical method development which is appropriate to the clinical phase.

Consort’s long tradition of technical expertise in research and development is driven by our team of innovative PhD level chemists and experienced analytical scientists who work alongside dedicated project managers to oversee each project from beginning to end, offering individual support.

We focus on developing processes that are safe, reproducible and commercially viable. By handling a project from pre-clinical through to Phase III and commercial supply, our dedicated project teams offer close communication with the customer and reduced risk and complexity in the supply chain.

  • Our fully-equipped Development Lab allows rapid development of scalable and robust chemical processes utilising technologies such as parallel reactors and Design of Experiments (DoE) methodologies.
  • Our flexible Kilo Lab operates to cGMP standards can handle multi-stage, complex processes while producing batches up to 5kg.
  • Finally, our modern Pilot Plant is able to deliver batch sizes of 10 to 50kg, and has capability to handle controlled drugs with the flexibility to handle potent materials if required.
  • All supported with full analytical development services, including stability testing and storage capability.

We determine both the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for all of our API processes using a combination of traditional and modern techniques, including Design of Experiments (DoE). Our expertise in the areas of process and method optimisation ensures high levels of product quality and compliance every time.


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