Standards & Regulation

A personal experience led us to examine how adverse drug events data can be used to benefit the industry.

The serialization deadlines are coming. It may seem an age away, but preparing for serialization is not as straightforward as you may think. Do you really want to get left behind?

The final deadline for the European Union’s REACH regulation is approaching – and the home stretch will be the most challenging, especially for pharma companies that have failed to recognize their role.

From anti-cancer viruses to H3 blocking narcolepsy drugs – we present a year in European drug approvals

Are you worried about implementing new manufacturing technology in your plant? Never fear, the FDA’s Emerging Technology Team may be able to lend a helping hand

2015 has been a difficult year for Indian pharma companies – and ASSOCHAM is calling for the country to get its “house in order”.

Digesting regulatory guidance is not always easy, but understanding the main points – and then paying attention to the details – will improve your chances of success.

New technologies for extractables and leachables testing of small molecules and biopharmaceuticals.

We sit down with Siu Ping Lam, Director of Licensing Division at the UK's Medicines and MHRA.

“The best-laid schemes o’mice an’ men” often go awry – and that can apply to your outsourcing plans.