What's happening?

Developments such as the consolidation of the outsourcing space and the upcoming serialisation regulations in Europe are influencing today’s pharmaceutical industry.

The 29th March 2018 marked the one-year countdown to Brexit. While many companies in the pharma industry are campaigning for a ‘soft’ exit from the EU, there is a risk that the complexity and bureaucracy of the regulatory landscape will increase dramatically if a ‘hard’ Brexit is implemented.

Times have changed. The pharmaceutical contract services landscape is more competitive than ever, with CDMOs continuing to develop their service offering and implementing strategies to help them stand out in the marketplace. The quality of manufacturing is no longer the sole decision-making factor.

In early drug development, the toxicology, bioavailability, pharmacokinetics (PK) and pharmacology of a compound need to be analysed using a liquid formulation. Often solubility becomes a challenge, meaning excipients are needed to optimise the solubility.

The US Food and Drug Administration (FDA) released the Standardisation of Data and Documentation Practices for Product Tracing guidance last week, which extends the standards outlined in the Drug Supply Chain Security Act (DSCSA).

The European Medicines Verification Organisation (EMVO) recently published an announcement to confirm that only marketing authorisation holders (MAHs) or parallel distributors (MAH with parallel di

As we move into 2018 there are a number of trends we can expect to drive activity in the pharmaceutical industry over the coming months.

Friday 9th February marks one year until the EU Falsified Medicines Directive (FMD) enforcement date. Although a year may sound like a long time it’s a very short period to implement a lot of changes.

Over the last decade the pharmaceutical industry has experienced unprecedented growth and is estimated to reach $1.5trillion by 2021. This has been driven by an increasing number of breakthrough therapies, expensive treatments for unmet medical needs and an ageing population.

Fredrik Lehmann PhD, General Manager and Sales Director Preclinical and Chemistry Services at Recipharm, partners with Uppsala Bio to discuss the global services in pharmaceutical development provided by Recipharm’s development facility in Uppsala.