What's happening?

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.

In recent years, pharmaceutical outsourcing has grown in popularity amongst drug developers across the industry. Companies are increasingly outsourcing to contract development and manufacturing organisations (CDMOs) due to the benefits outside expertise can bring to their business.

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.

As we move into 2018, compliance with serialisation regulations is becoming more and more urgent. Implementing suitable solutions puts pressure on contract manufacturing organisations’ (CMOs) internal infrastructure as they find a way to introduce and integrate serialisation with their current systems and improve supply chain communication.

According to PwC, the counterfeit drug market is worth over $200 billion per annum. In recent months the pharmaceutical industry has taken huge steps to tackle the rising problem of falsified medicines with the introduction of serialisation regulations in more than 50 countries worldwide.