Harmonizing Product Information Across Baltic Markets

Navigating multilingual product information across several markets can be complex – but it doesn’t have to be.
In this case study, we share how one of our partner companies successfully harmonized their SmPC, PIL, and labelling across the Baltic region, working with our medical writing experts.

Discover how we:

Reduced inconsistencies between country-specific documents
Speeded up approval timelines with fewer authority questions
Simplified ongoing maintenance of product information
Developed Clinical Overview with clinical justification

Download the case study to learn how our medical writing team can support your cross-market needs, visit.

Signal Detection: An Integrated Approach to Pharmacovigilance & Regulatory Compliance

Early detection of safety signals is key to pharmacovigilance, helping identify potential risks from clinical trials, post-marketing surveillance, and scientific literature. Our experts ensure these signals are managed effectively through processes that: Validate,...

Global Literature Review: Ensuring Safety through Robust Processes

In pharmacovigilance, timely identification of safety signals is essential to protecting patients – which is why our Global Literature Review (GLR) process provides a systematic and reliable way to capture, analyze, and document safety data from trusted scientific...

Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

In 2025, pharmacovigilance outsourcing has become essential for biotech companies working to stay compliant and protect patient safety. The European Medicines Agency’s latest report showed a nearly 29% increase in inspections, underscoring the rise in regulatory...

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Harmonizing Product Information Across Baltic Markets

Signal Detection: An Integrated Approach to Pharmacovigilance & Regulatory Compliance

Global Literature Review: Ensuring Safety through Robust Processes

Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

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Big Enough To Cover All Your Needs.Small Enough To Care.

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Harmonizing Product Information Across Baltic Markets

Signal Detection: An Integrated Approach to Pharmacovigilance & Regulatory Compliance

Global Literature Review: Ensuring Safety through Robust Processes

Pharmacovigilance outsourcing for boosting compliance and safety for biotech companies

Big Enough To Cover All Your Needs. Small Enough To Care.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information

Clinical Trials

PV System & QPPV

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