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.

Whitepaper: Computerised System Validation & Pharmacovigilance

Whitepaper: Computerised System Validation & Pharmacovigilance

Gain insights into optimised CSV solutions, and their role in effective risk management. Key Highlights: In-depth CSV risk management strategies Ensuring data integrity and reliability in PV systems Case study on validating a cloud-based safety database At Biomapas,...

Breaking silos across Medical Information & Pharmacovigilance

Breaking silos across Medical Information & Pharmacovigilance

Discover solutions for effective PV & MI data management, including handling Adverse Events, Product Quality Complaints, and MI inquiries. Our experts will walk you through real-life examples and hands-on solutions. Looking to improve your PV & MI data...

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

Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Medical Information