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

High Potency Drug Manufacturing: Molecule to Market

PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients...

Patient Centric Clinical Trials

The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and...

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