Regulatory lifecycle management is a major task when your product is approved in multiple countries. You must consider each countries process, regulations and timelines when filing a variation. It is important to understand these complexities to develop an efficient plan of action. We interviewed our regulatory...

The ICH CTD (Common Technical Document is a structure, format and set of requirements for application dossiers for the registration of medicinal therapeutics (pharmaceuticals, biologics and ATMPs). It is widely used across the US, Europe, Japan and many other countries. Many regulatory affairs professionals are...

A combination product refers to a medical device that contains an element of a pharmaceutical. Recognising this and understanding which regulations need to be met is essential to ensure the successful marketing of your product. Educo Life Sciences caught up with Richard Young, who explained some...

We interviewed Educo Life Sciences trainer Raz who teaches on the CMC Essentials course. During our discussion, we delved into the significant challenges that small biotech start-ups encounter when embarking on CMC development. Importantly, Raz also offered valuable insights into potential solutions to overcome these...

We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of a drug in history. Watch the full interview below: [embed]https://youtu.be/-4B6qiVuM9Y[/embed]   Why Can't We Develop...

  We interviewed Educo Life Sciences trainer Sophie Nageotte to get her views on a career in pharmaceutical regulatory affairs, specifically CMC. Sophie discusses her career experiences and provides some advice for those working in regulatory CMC. She also discusses why CMC regs is an exciting...

We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical industry and John highlights alternative routes that are perfect for non-scientists. In this...

We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical trials, digitalisation & AI and agile working. You can watch or read the video below.   Watch...