Drug Development

Articles

Operators are hit hard by breakage problems and strike out on FDA inspections.

Hits and Strikes

The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.

Effective complaint handling, investigations and adverse event reporting

...some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence...

Joining the parallel lines

All commercial sponsors want to maximize their profit and, with a population close to 500 million, the EU is an enormous potential marketplace that they simply cannot ignore!

Regulatory affairs: additional value?

The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.

Drinking from a fire hose

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

Suspicious Times

They may have seemed harmless at first, but these ideas took a big bite.

Deviations and Delays

At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.

The road to free validation

How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?

Is pharma's supply chain safe?

Customers complaining lead to some serious explaining.

Process and Scaling