Regulatory Archives - Schlafender Hase

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.

< 1 minute read

Preparing for FHIR-based ePI – How a Proofreading Solution Supports your ePI Journey

As regulatory bodies move toward structured electronic product information (ePI) in FHIR XML format, life sciences organizations are under pressure to evolve. That includes how you verify and proofread content.

2 minutes read

How are increased compliance requirements impacting medical devices?

How are increased compliance requirements impacting medical devices? Discover the Future of Medical Device Regulation.We will dive into the rapid growth of the medical device sector, driven by cutting-edge technologies and rising regulatory requirements.

4 minutes read

The medical device sector’s surging regulatory burden: how are suppliers coping?

2 minutes read

Learning the New Language of the EMA & The FDA: FHIR

Watch our interactive discussion session focusing on the evolution and outlook of Fast Healthcare Interoperability Resources (FHIR).FHIR represents a significant step in how we manage and exchange information and is rapidly gaining acceptance. In this session, industry experts will provide an introduction to the FHIR initiative, explore some current applications as well as the impacts, benefits and prospective timelines.

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From Struggles to Solutions – Leveraging Technology for Faster Labeling Review in Crop Science

Across the Crop Science sector, both user and environmental safety are of highest priority. In this buyer’s guide, we will go over seven steps that will help you in your purchasing process, to ensure that you end up with the proofreading software you need.

3 minutes read

Rising regulatory demands: are medical device suppliers ready?

The global medical devices market is set to reach $886.80 billion in value by 2032 . As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing.

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The Role of Barcodes in Life Sciences, and the Key to Ensuring Barcode Accuracy

As the world shifts towards electronically delivered e-Labeling, it's essential to stay ahead of the game. Regulatory Authorities are now permitting and encouraging online e-PIL content, with other regions follow suit.

3 minutes read

How TVT helps the Top 5 Functions of Regulatory Professionals

The challenges faced by regulatory professionals are substantial. New products must be brought to market quickly and the pressure is on to turn projects around faster. Furthermore, regulations are constantly evolving, which means labeling and packaging must be updated.

Regulatory

The Role of Quality Assurance in Reducing Regulatory Risks

Preparing for FHIR-based ePI – How a Proofreading Solution Supports your ePI Journey

The Essential Artwork Approval Checklist for Regulatory Affairs Professionals

How are increased compliance requirements impacting medical devices?

The medical device sector’s surging regulatory burden: how are suppliers coping?

Learning the New Language of the EMA & The FDA: FHIR

From Struggles to Solutions – Leveraging Technology for Faster Labeling Review in Crop Science

Rising regulatory demands: are medical device suppliers ready?

The Role of Barcodes in Life Sciences, and the Key to Ensuring Barcode Accuracy

How TVT helps the Top 5 Functions of Regulatory Professionals