What's happening?

Understanding regional differences, implementing best-practice documentation processes key to successful approval outcomes 

Customers want us to keep control of any potential issues that can arise from the molecule – this demand comes from them and it has sometimes been a surprise when the molecule is already known. 

As pipelines expand and outsourcing manufacturing activity continues to increase, demand within the pharmaceutical industry is thriving. 

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.

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.

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. 

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.

The enforcement of the EU Falsified Medicines Directive (FMD) in February 2019 saw the serialisation of pharmaceutical products become a legal requirement.

Industrialising inhalation products requires specialist knowledge, a comprehensive manufacturing strategy and comprehensive product maintenance in order to overcome potential hurdles during commercial scale production.

Archie Wall,  Karl Nicholls, Mikael B. Caspersen, Stig Skrivergaard,  Kenneth A. Howard,  Kersti Karu,  Vijay Chudasama and James R. Baker
  Org. Biomol. Chem., 2019, Advance Article

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.