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September 27, 2017

Schlafender Hase Team

Form and Substance

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.

June 14, 2017

Schlafender Hase Team

In Perfect Harmony? What will Brexit Mean for Regulatory Harmonisation

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).

September 1, 2016

Schlafender Hase Team

Regulators Hunger for Control of Nutrition and Nutraceuticals

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.

August 30, 2016

Schlafender Hase Team

The Long Arm of the Regulator

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.

August 1, 2016

Schlafender Hase Team

Food and Pharma: The Broadening Reach of Regulators

Its new Nutrition Facts label guidance, which applies to packaged foods, will ensure that labelling reflects the latest scientific information, including the link between diet and chronic diseases, for example. New requirements also include updated serving sizes, and a refreshed design which highlights information such as calorie content, portion size, added sugar content. New nutrients must be declared too, including Vitamin D and potassium, to combat associated deficiencies.

July 27, 2016

Schlafender Hase Team

Food Follows Pharma into Tighter Regulatory Territory

In the fast-growing nutraceuticals market, rules are becoming stricter too. Authorities in Scandinavia are clear that if nutrition companies are going to start making medicinal claims about their products, they must categorise themselves as pharmaceutical businesses and be bound by similar requirements. And countries from Japan and India to Canada have already put the regulatory wheels in motion.

July 4, 2016

Schlafender Hase Team

The Great Brain Drain

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.

July 2, 2016

Schlafender Hase Team

Empowering Experts, Retaining Talent

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.

June 22, 2016

Schlafender Hase Team

Swerving the Talent Trap

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.