Resources

Implications for Shipping of Clinical Materials into the European Market

Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mould on paracetamol (acetaminophen) tablets

Six Strategies to Stretch Your Limited Clinical Study Drug Supply

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex

EU Good Manufacturing Practice ANNEX 13 Investigational Medicinal Products

Can you imagine working for months to ensure your clinical supply strategy is in place for your European studies, only to have them be delayed because labeling requirements were out of compliance, and the QP or the site(s) rejected the materials you

Clinical Packaging and what Your Clinical Study Design Reveals About Your Needs.

As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Today’s sponsors must be able to manage and coordinate multiple resources, processes, and locations with speed and accuracy to design effective

PCI Brexit Communication, 12th April 2019

The European Council and the UK Prime Minister have agreed and announced an extension to Article 50 with a flexible Brexit delay until 31st October 2019, with a review at the end of June. However, the UK will be able to leave the EU before this Octob

PCI Brexit Communication, 3rd April 2019

On the 29th March 2019, a vote took place on the proposed first stage of the renegotiated Brexit deal by the United Kingdom (UK) Parliament. The plan was subsequently rejected and as a result, the extended deadline agreed during the EU Summit on the

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