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Cross-border compliance efforts

April 10, 2017

Schlafender Hase Team

Life Sciences’ Shifting Sands: 5 Trends that Threaten the Status Quo

Change is the only constant in the new normal, something that applies as much to life sciences now as to other markets more readily associated with disruption, such as retail and banking. But the pharmaceutical industry is not known for its adaptability, so how will it weather the choppy conditions currently characterising the market - and can technology ease the strain?

Cross-border compliance efforts
  • April 10, 2017
  • By: Marc Chaillou
5 minutes read

Life Sciences’ Shifting Sands: 5 Trends that Threaten the Status Quo

Change is the only constant in the new normal, something that applies as much to life sciences now as to other markets more readily associated with disruption, such as retail and banking. But the pharmaceutical industry is not known for its adaptability, so how will it weather the choppy conditions currently characterising the market - and can technology ease the strain?

Correction Cycles

February 13, 2017

Schlafender Hase Team

Counting the Cost of Corrections in Clinical Trials Labeling

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.

Correction Cycles
  • February 13, 2017
  • By: Peter Muller
7 minutes read

Counting the Cost of Corrections in Clinical Trials Labeling

Within all of this, the clinical trials process carries its own particular share of risks and associated costs. If drugs do not pass human testing – and most don’t – all of the work that precedes this will have been for nothing: certainly it will not deliver the expected return. So life sciences companies need robust processes in place to ensure that products are taken absolutely correctly, leaving no scope for error in dosage, for example.

December 6, 2016

Schlafender Hase Team

Schlafender Hase Chooses Connectria to Host Custom Citrix Solution

ST. LOUIS, MO. (December 6, 2016) – Connectria Hosting, a global cloud hosting company and founder of the No Jerks Allowed® movement, today announced Schlafender Hase has chosen Connectria for a customized hosted Citrix solution.

  • December 6, 2016
2 minutes read

Schlafender Hase Chooses Connectria to Host Custom Citrix Solution

ST. LOUIS, MO. (December 6, 2016) – Connectria Hosting, a global cloud hosting company and founder of the No Jerks Allowed® movement, today announced Schlafender Hase has chosen Connectria for a customized hosted Citrix solution.

Regulators Hunger for Control of Nutrition and Nutraceuticals

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.

Regulators Hunger for Control of Nutrition and Nutraceuticals
  • September 1, 2016
  • By: Peter Muller
6 minutes read

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.

prominent trends in life sciences

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.

prominent trends in life sciences
  • August 30, 2016
  • By: Peter Muller
7 minutes read

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.

Food and Pharma Regulators

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.

Food and Pharma Regulators
  • August 1, 2016
  • By: Peter Muller
5 minutes read

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.

Food Follows Pharma into Tighter Regulatory Territory

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.

Food Follows Pharma into Tighter Regulatory Territory
  • July 27, 2016
  • By: Peter Muller
3 minutes read

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.

Food Labelling

July 18, 2016

Schlafender Hase Team

Food Labelling

Pharma has come a long way in refining its processes and harnessing technology to streamline workflow and tighten up reliability, so as an industry it provides a valuable reference point. One of the techniques a lot of companies here have adopted is an automated approach to label checks, using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork, irrespective of the font or language in use. Although humans should never be distanced entirely from critical checks, using reliable automation can save on several rounds of laborious proofreading and accelerate time to market, freeing up skilled resources for more specialist work.

Food Labelling
  • July 18, 2016
  • By: Peter Muller
4 minutes read

Food Labelling

Pharma has come a long way in refining its processes and harnessing technology to streamline workflow and tighten up reliability, so as an industry it provides a valuable reference point. One of the techniques a lot of companies here have adopted is an automated approach to label checks, using sophisticated text verification – a process which can very quickly pick up even the tiniest discrepancies between regulatory text, artwork briefs and packaging artwork, irrespective of the font or language in use. Although humans should never be distanced entirely from critical checks, using reliable automation can save on several rounds of laborious proofreading and accelerate time to market, freeing up skilled resources for more specialist work.

regulatory brain drain

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.

regulatory brain drain
  • July 4, 2016
  • By: Dr. Jutta Hohenhoerst
7 minutes read

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.

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