Regulatory

One practical way to get ahead is to harness automation in the preparation of data by identifying and selecting the definitive source documents; checking for updates; and aligning languages, fonts and other intricacies. Sophisticated tools are available that reliably and precisely compare files in different formats for the possible information they contain. This ability to quickly contrast content of similar documents from multiple sources in large batches could help save firms vast amounts of time in this substantial preparatory stage of getting the company’s product data assets in order.

The global market is currently experiencing a turbulent period, as national elections continue, governments change and the UK edges closer to Brexit. One of the practical concerns for life sciences is how this might affect the regulatory landscape, and momentum behind specific regulatory developments such as the phasing in of ISO Identification of Medicinal Products (IDMP).

The life sciences industry, keen to reduce its reliance on expensive blockbuster drugs, has recognised the opportunity and wants its share of the action. Many firms are now embracing health foods and nutraceuticals through acquisition or partnership, or the expansion of existing businesses to include new divisions.

It is no coincidence that the food and nutraceuticals industries are now beginning to look to these more experienced sectors – particularly pharma - for guidance on best practices – and as a source of regulatory professionals as they seek to bolster their teams.

Manual tasks are unrewarding, demotivating and a poor use of qualified professionals’ time. So it is far from ideal that the life sciences industry is using scientific writers with PhDs to check over content for regulatory/QA purposes, at great expense to the business. Avoiding a product recall or safety scare is clearly in everyone’s interests, but there must be a better way.

Even without the implications of Brexit, these are turbulent times for regulatory teams. Compliance has become a full-time job, and administrative demands are on a permanently upward trajectory.

Regulatory requirements are increasing all the time in life sciences, and recently it has seemed as though the rate of release of new guidelines and directives is accelerating.