Applied Regulatory Consulting

Tim Felgate has developed an extensive collection of links to some useful regulatory intelligence sources and other sites which are useful to regulatory professionals working with medicines. These can be found at reg-info.com. The site is maintained by Applied Regulatory Consulting Ltd.

We have developed a customised search which uses Google to conduct a search of the web sites of the European Regulatory Agencies for medicinal products (both the national and pan-European bodies such as the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies).

We have compiled a table of links to a number of useful glossaries which help to demystify some of the terminology relating to the regulation of medicines.

Here are links to some links we have put together:

• European Regulatory Bodies
• EU National Agencies
• European Public Assessment Reports
• Search EU Regulatory Agencies and Authorities (medicinal products)
• CTD guidelines
• Electronic Submissions
• European Clinical Trials Directives