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Regulatory Guidelines for Labeling in Pharma

May 23, 2023

Schlafender Hase Team

Regulatory Guidelines for Labeling in Pharma

Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

Regulatory Guidelines for Labeling in Pharma
  • May 23, 2023
  • By: Peter Muller
4 minutes read

Regulatory Guidelines for Labeling in Pharma

Pharmaceutical labeling is a critical element of healthcare products and services that are strictly regulated by health authorities. This includes the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The FDA oversees the safety and efficacy of pharmaceutical drugs, biopharmaceuticals, and other healthcare products. As a result, pharmaceutical labeling is a complex and meticulous process, with even minor errors resulting in significant consequences.

RAPS Premium Sponsor

May 8, 2023

Schlafender Hase Team

Regulatory Affairs – Partnering for Knowledge

As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

RAPS Premium Sponsor
  • May 8, 2023
  • By: Peter Muller
2 minutes read

Regulatory Affairs – Partnering for Knowledge

As a company that was built around a specific need for Regulatory Affairs (RA), we must also remain on top of regulatory developments. Ensuring our software continues to meet the needs of RA professionals. Our top resource is RAPS, the Regulatory Affairs Professionals Society and in this article we look at our partnership with RAPS and the importance of this organization.  

Pharmaceutical Label Requirements

May 3, 2023

Schlafender Hase Team

Why is labeling important in the pharmaceutical industry?

Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

Pharmaceutical Label Requirements
  • May 3, 2023
  • By: Dean Halliday
4 minutes read

Why is labeling important in the pharmaceutical industry?

Bringing a new drug to market demands a large investment on the part of a pharmaceutical company – often, $ 1 billion or more. Ensuring compliance with complex labeling regulations is part of that investment. In the following we look at why pharmaceutical labeling is so important and the different types of labeling.

What is a document comparison software?

March 15, 2023

Schlafender Hase Team

What is Document Comparison Software For Regulatory Affairs?

The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting a software for document comparison. Like other technologies, this too has been a slow adoption despite it’s proven time, money, and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs tech stack.

What is a document comparison software?
  • March 15, 2023
  • By: Philipp Thomas
5 minutes read

What is Document Comparison Software For Regulatory Affairs?

The major players in the Pharma and Medical Devices industries have either adopted or are in the process of adopting a software for document comparison. Like other technologies, this too has been a slow adoption despite it’s proven time, money, and stress savings. The goal of this article is to explain how document comparison software can help and why it is an essential part of any Regulatory Affairs tech stack.

E-Labelling: Practical Next Steps for Medical Device Manufacturers

March 6, 2023

Schlafender Hase Team

E-Labelling: Practical Next Steps for Medical Device Manufacturers

Practical next steps for medical device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

E-Labelling: Practical Next Steps for Medical Device Manufacturers
  • March 6, 2023
  • By: Schlafender Hase
4 minutes read

E-Labelling: Practical Next Steps for Medical Device Manufacturers

Practical next steps for medical device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts.

8_WAYS_TO_GET_YOUR_PRODUCT_TO_MARKET_FASTER

March 2, 2023

Schlafender Hase Team

8 Ways RA can help get Products to Market Faster

Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.

8_WAYS_TO_GET_YOUR_PRODUCT_TO_MARKET_FASTER
  • March 2, 2023
  • By: Philipp Thomas
5 minutes read

8 Ways RA can help get Products to Market Faster

Bringing a new drug to market is time-consuming and costly, and generally takes 10 years and costs over $1 billion. The smallest lapse in labeling and packaging can jeopardize even the most well-planned submission. A proofreading and comparison software can help you get there faster, safer.

5 Ways You’re Wasting Time & Money in Regulatory Affairs

March 1, 2023

Schlafender Hase Team

5 Ways You’re Wasting Time & Money in Regulatory Affairs

If you are proofreading manually, you are aware of how time-consuming it is.We have all heard the saying “time is money”, and this is very true for Regulatory Affairs professionals. In this article, we'll be exploring proofreading in Regulatory Affairs, and 5 ways that RA depts. are wasting money by relying on manual proofreading.

5 Ways You’re Wasting Time & Money in Regulatory Affairs
  • March 1, 2023
  • By: Dean Halliday
5 minutes read

5 Ways You’re Wasting Time & Money in Regulatory Affairs

If you are proofreading manually, you are aware of how time-consuming it is.We have all heard the saying “time is money”, and this is very true for Regulatory Affairs professionals. In this article, we'll be exploring proofreading in Regulatory Affairs, and 5 ways that RA depts. are wasting money by relying on manual proofreading.

Choosing comparison software

February 2, 2023

Schlafender Hase Team

13 Questions to Ask When Choosing Comparison Software

Settling on a text comparison solution that does not require you to change your existing processes can be a daunting task, but we are here to help! We’ve outlined 13 questions for you to ask before making your final choice.

Choosing comparison software
  • February 2, 2023
  • By: Peter Muller
4 minutes read

13 Questions to Ask When Choosing Comparison Software

Settling on a text comparison solution that does not require you to change your existing processes can be a daunting task, but we are here to help! We’ve outlined 13 questions for you to ask before making your final choice.

Proofreading Is Easier with TVT

November 10, 2022

Schlafender Hase Team

11 Ways Proofreading Is Easier with TVT 11

Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.

Proofreading Is Easier with TVT
  • November 10, 2022
  • By: Mike Baird
3 minutes read

11 Ways Proofreading Is Easier with TVT 11

Using a proofreading software like TVT®, takes the stress out of proofreading by automating tasks.

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