Glemser’s Journey

In an industry that is always evolving, technology providers must do more than just react. They must respond.

For over 25 years, Glemser has adapted to every charge and change—enhancing our ComplianceAuthor AI®

platform, deepening our expertise, and ensuring consistency, safety, and compliance for our clients.

1996

QRD

EMA introduces QRD as a required output for product labeling, supporting standardized regulatory submissions across Europe.

Glemser offers document management solutions for label authors to create label content from approved QRD templates.

EMA REGULATIONS

2001

Directive 2001/83/EC

EMA establishes standardized requirements for product labeling across the EU to ensure consistency and patient safety.

Glemser supports the harmonization of multilingual labeling by offering structured content solutions, ensuring clear and compliant labels for cross-border distribution.

EMA REGULATIONS

2009

SPL & Electronic Submission

FDA requires pharmaceutical companies to submit drug labeling in structured XML format for global standardization.

In response, Glemser enhances ComplianceAuthor® legacy solution to generate SPLs on demand, a tool that continues to serve clients today.

FDA REGULATIONS

2012

Pharmacovigilance Legislation

EMA introduces stricter safety monitoring requirements, mandating updated safety information and warnings on product labels for real-time risk management.

Glemser’s structured content solutions maintain compliance with evolving safety and transparency requirements.

EMA REGULATIONS

2015

Move to Cloud Based / SaaS

Industry shifts to cloud-based solutions, enhancing flexibility, scalability, and accessibility for regulatory submissions.

Glemser modernizes its offering by transitioning from on-premise to cloud-based solutions, supporting implementations on AWS and Azure.

INDUSTRY / TECHNOLOGICAL CHANGES

2020

EU ePI

The EMA advances the digital transformation of product labeling by promoting structured electronic formats, enabling centralized updates and improving accessibility for patients and healthcare professionals in a multilingual, digital-first environment.

Glemser integrates ePI FHIR and Pharmaledger outputs and provides ePI conversion services to clients.

EMA REGULATIONS

2021

Generative AI

AI gains momentum, driving advancements in natural language processing (NLP) and large-language models (LLM).

Glemser incorporates NLP and generative AI into ComplianceAuthor AI®, improving its capabilities for streamlined content creation and compliance.

INDUSTRY / TECHNOLOGICAL CHANGES

2024

Inflation Reduction Act

Price controls on the top 100 pharmaceutical products in the market impacts profitability for many companies.

Glemser’s ComplianceAuthor AI® solution helps companies maintain productivity and efficiency, enabling more with fewer resources in response to reduced profitability.

INDUSTRY / TECHNOLOGICAL CHANGES

ChatGPT 4.0

ChatGPT 4.0 is released, advancing AI’s capabilities even futher.

Glemser integrates automated document ingestion and AI author assistance into ComplianceAuthor AI®, prioritizing efficiency and accurate content creation.