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Pharma and Medical Device Technology

May 27, 2025

Schlafender Hase Team

How Pharma and Medical Device Technology Is Evolving to Meet Growing Industry Demands

The pharmaceutical and medical device sectors are undergoing significant transformation. Faced with growing regulatory demands, the rapid pace of globalization, and higher market expectations, the pressure to deliver safe, effective products faster and more efficiently is now greater than ever before.

Pharma and Medical Device Technology
  • May 27, 2025
  • By: Katarina Kresankova
5 minutes read

How Pharma and Medical Device Technology Is Evolving to Meet Growing Industry Demands

The pharmaceutical and medical device sectors are undergoing significant transformation. Faced with growing regulatory demands, the rapid pace of globalization, and higher market expectations, the pressure to deliver safe, effective products faster and more efficiently is now greater than ever before.

The Role of Quality Assurance in Reducing Regulatory Risks

May 13, 2025

Schlafender Hase Team

The Role of Quality Assurance in Reducing Regulatory Risks

Quality management is a crucial element in any operations. However, it is especially important for regulatory affairs professionals in regulated industries such as pharmaceuticals and medical devices, as well as in fast-moving consumer goods sectors (FMCGs) like food and cosmetics. Quality assurance provides the basis for market approval, helping prevent quality lapses that could trigger compliance actions or endanger public safety.

The Role of Quality Assurance in Reducing Regulatory Risks
  • May 13, 2025
  • By: Katarina Kresankova
4 minutes read

The Role of Quality Assurance in Reducing Regulatory Risks

Quality management is a crucial element in any operations. However, it is especially important for regulatory affairs professionals in regulated industries such as pharmaceuticals and medical devices, as well as in fast-moving consumer goods sectors (FMCGs) like food and cosmetics. Quality assurance provides the basis for market approval, helping prevent quality lapses that could trigger compliance actions or endanger public safety.

The Essential Artwork Approval Checklist

May 2, 2025

Schlafender Hase Team

The Essential Artwork Approval Checklist for Regulatory Affairs Professionals

Artwork approval is a crucial step for regulatory affairs (RA) professionals in labeling and packaging. Even minor oversights can lead to non-compliance, costly product recalls, and submission and product launch delays. To help navigate this complex process, we’ve compiled an essential artwork approval checklist that will streamline approvals, ensure compliance, and protect brand integrity.

The Essential Artwork Approval Checklist
  • May 2, 2025
  • By: Peter Muller
6 minutes read

The Essential Artwork Approval Checklist for Regulatory Affairs Professionals

Artwork approval is a crucial step for regulatory affairs (RA) professionals in labeling and packaging. Even minor oversights can lead to non-compliance, costly product recalls, and submission and product launch delays. To help navigate this complex process, we’ve compiled an essential artwork approval checklist that will streamline approvals, ensure compliance, and protect brand integrity.

Automating the Artwork Approval Process

April 11, 2025

Schlafender Hase Team

Automating The Artwork Review Process

Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.

Automating the Artwork Approval Process
  • April 11, 2025
  • By: Marc Chaillou
3 minutes read

Automating The Artwork Review Process

Speed to market is king in the fast-moving world of consumer goods. Yet, countless hours are spent reviewing packaging artwork before going to market. Traditional review methods are time-consuming and prone to human error. A single mistake in an ingredient list or a barcode could result in lost sales or shelf space, a recall and damage to the brand reputation.

Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork

April 2, 2025

Schlafender Hase Team

Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork

Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.

Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork
  • April 2, 2025
  • By: Vineed Ravindranath
6 minutes read

Navigating FDA Guidelines for Pharmaceutical Packaging: A Focus on Packaging Artwork

Pharmaceutical packaging plays a critical role in ensuring the safety, efficacy, and quality of medications. The US Food and Drug Administration (FDA) closely regulates packaging and labeling, as well as manufacturing processes in pharmaceutical packaging. Ultimately, these regulations and guidelines safeguard patient health.

Top Regulatory Challenges in Food Labeling

March 13, 2025

Schlafender Hase Team

Top Regulatory Challenges in Food Labeling and How to Overcome Them

Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.

Top Regulatory Challenges in Food Labeling
  • March 13, 2025
  • By: Mike Baird
6 minutes read

Top Regulatory Challenges in Food Labeling and How to Overcome Them

Food labeling plays a crucial role in protecting consumer health by providing information relating to food sources, nutrition and safety. Accurate and informative food labeling allows consumers to make informed dietary choices. Compliance with food labeling regulations is not only a legal requirement but also impacts brand reputation.

Discussion with Rote Liste

March 11, 2025

Schlafender Hase Team

The Future of Patient Information: A Discussion on GI 4.0® with Manuela Wiegand from Rote Liste

The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.

Discussion with Rote Liste
  • March 11, 2025
  • By: Philipp Thomas
4 minutes read

The Future of Patient Information: A Discussion on GI 4.0® with Manuela Wiegand from Rote Liste

The way patients access critical medication information is evolving. In this expert discussion, Philipp Thomas from Schlafender Hase speaks with Manuela Wiegand, pharmacist at Rote Liste® Service GmbH, about Gebrauchsinformation 4.0 (GI 4.0®)—Germany’s move toward digital patient information leaflets.

Promotional Compliance

March 10, 2025

Schlafender Hase Team

Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

Promotional Compliance
  • March 10, 2025
  • By: Peter Muller
5 minutes read

Increased Focus on Promotional Compliance – Insights from OPDP and PAAB

In mid-2024, new US Food and Drug Administration (FDA) rules came into force for prescription drug advertising on television and radio. These rules are designed to promote more clarity, [1] and we can also expect future changes affecting social media influencers, especially when promoting weight loss drugs.

Ensure Compliance in Cosmetic Labeling

March 7, 2025

Schlafender Hase Team

Ensure Compliance with the Latest Cosmetic Trends and Regulations

As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.

Ensure Compliance in Cosmetic Labeling
  • March 7, 2025
  • By: Marc Chaillou
5 minutes read

Ensure Compliance with the Latest Cosmetic Trends and Regulations

As cosmetic regulations evolve, maintaining labeling standards is becoming increasingly complex. Here we explore some key changes in cosmetic labeling regulations and highlight how to ensure your products meet all requirements.

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