During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.

The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.

The biggest benefit that has been brought about by the compulsory labelling of allergens in food is the greater degree of cooperation that has been established between food manufacturers and their suppliers.

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.

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!

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.

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

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.

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?