Quality by Design (QbD) allows for a systematic approach to drug development that is intended to improve quality by using analytical and risk-management methodologies for the design, development and manufacturing of new medications. The approach primarily aims to design quality into workflows from the outset.
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With demand for CDMO services only set to grow in the coming years, the sector will continue to shape itself in order to meet the ever-evolving needs of developers.
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Over the past decade the pharmaceutical industry has seen a surge in merger and acquisition (M&A) transactions. Among the several factors influencing consolidation, a primary driver of pharmaceutical M&A activity is the ability to minimise supply chain complexities.
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We have spent the last five years after the IPO building a global platform, getting a broad range of technologies and extending our customer base.
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The enforcement of the EU Falsified Medicines Directive (FMD) in February 2019 saw the serialisation of pharmaceutical products become a legal requirement.
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Industrialising inhalation products requires specialist knowledge, a comprehensive manufacturing strategy and comprehensive product maintenance in order to overcome potential hurdles during commercial scale production.
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Org. Biomol. Chem., 2019, Advance Article
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With the ability to control the rate and site of drug release to reach clinical objectives that cannot be achieved using conventional dosage forms, modified-release (MR) drug delivery offers many advantages.
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While the development of new inhalation therapy drugs is growing in popularity, the tech transfer and scale-up stages present several complexities that are difficult for manufacturers to manage.
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Following the enforcement of the EU Falsified Medicines Directive (FMD) in February 2019, serialisation is a legal requirement for pharmaceutical products.