We keep promises. Always

Prof. Audrius Sveikata MD, PhD, CEO, Co-Founder

 

The passion and experience
of our people ensures timely
execution every time.

Juozas Buitkus, MEcon, Chief Operating Officer

 

WE ARE YOUR TRUSTED PARTNER FOR
QUALITY AND DATA INTEGRITY IN REGIONS
WITH HIGH RECRUITMENT POTENTIAL.

Regina Auškalnienė MD, Director Clinical Operations

 

PROJECT COMPLEXITY AND PRODUCT
DIVERSITY MAKE REGULATORY
AFFAIRS EXCITING.

Mindaugas Broga, MBA, LLM, MEth, Director Regulatory Affairs

 

A culture of quality comes
from the right habits.

Egidija Pauriene, MD, Quality Assurance Director

Biomapas is a clinical, regulatory and pharmacovigilance solution provider to the global life science industry.

Clinical Research

Regulatory Affairs

Pharmacovigilance

Reasons to choose us:

Geographical Reach

We have personnel in place in 60+ countries for pharmacovigilance support, 50+ for regulatory, and 20+ for clinical.

Patient Recruitment

We are particularly strong in countries such as Eastern Europe and the CIS region where patient recruitment is fast and reliable. Investigators are keen to participate in trials due to less competition and more treatment naïve patients.

Regulatory / Pharmacovigilance

Our Regulatory and Pharmacovigilance teams provide Marketing Authorization Holders with the entire function or can provide just single activities.

Early Phase Unit

Large, state-of-the-art early Phase unit located in Lithuania's leading university hospital, Santaros Klinikos, with an extensive patient database.

High Value

We remain very competitively priced despite providing highly qualified, experienced and efficient personnel. GxP compliance, data integrity assured, and careful oversight of quality.

Customer Satisfaction

We have 90% repeat business due to consistent on-time delivery, our communications are timely, clear and precise, and we readily adapt to changing needs. We keep promises, always.

Clinical Research

We provide full-service solutions for Phase I-IV clinical research and for medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas.

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Early Phase Unit (Lithuania)
Strategic Feasibility Studies
Regulatory and Ethics Committee Submissions
Clinical Monitoring
Project Management

Quality and Compliance
Clinical Trial Materials and IMP Management
EDC, Data Management and Biostatistics
Medical Writing
Legal Representation in EU and Switzerland

Dossier Development / Medical Writing
Pre-submission Assessment
CP, DCP, MRP and National Procedures
eCTD and NeeS compilation

Marketing Authorization Holder Service
Product Lifecycle Management
Local Regulatory Support / Representation
Medical Devices and IVD Devices

Regulatory Affairs

Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements.  Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences.

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Pharmacovigilance

Our pharmacovigilance support ranges from full, 24/7 assistance service with global coverage, to tailored services based on clients’ needs.

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Clinical Safety
Medical Monitoring
Pharmacovigilance System
EudraVigilance (including XEVMPD) Support

Pharmacovigilance Database
Materiovigilance
Loocal Pharmacovigilance Representation
Medical Information

Geographical Coverage

Covered areas are highlighted in green

North America
Canada
United States

LATAM
Brazil
Mexico

CIS REGION
Armenia
Azerbaijan
Belarus
Georgia
Kazakhstan
Kyrgyzstan
Moldova
Mongolia
Russia
Tajikistan
Turkmenistan
Ukraine
Uzbekistan

Western Europe
Austria
Belgium
France
Germany
Ireland
Italy
Luxembourg
Switzerland
The Netherlands
Portugal
Spain
United Kingdom
Liechtenstein

Northern Europe
Finland
Sweden
Norway
Denmark
Iceland
Lithuania
Latvia
Estonia

Central, East and South Europe
Bulgaria
Hungary
Romania
Poland
Czech Republic
Slovakia
Slovenia
Croatia
Serbia
Macedonia
Montenegro
Albania
Malta
Cyprus
Greece Bosnia and Herzegovina
Turkey

CIS REGION
Armenia
Azerbaijan
Belarus
Georgia
Kazakhstan
Kyrgyzstan
Moldova
Mongolia
Russia
Tajikistan
Turkmenistan
Ukraine
Uzbekistan

Western Europe
Austria
Belgium
France
Germany
Ireland
Italy
Luxembourg
Switzerland
The Netherlands
Portugal
Spain
United Kingdom
Liechtenstein

Northern Europe
Finland
Sweden
Norway
Denmark
Iceland
Lithuania
Latvia
Estonia

Central, East and South Europe
Bulgaria
Hungary
Romania
Poland
Czech Republic
Slovakia
Slovenia
Croatia
Serbia
Macedonia
Montenegro
Albania
Malta
Cyprus
Greece
Bosnia and Herzegovina
Turkey

CIS Region
Armenia
Belarus
Georgia
Moldova
Russia
Ukraine

Central and Eastern Europe
Austria
Switzerland
Czech Republic
Poland
Slovakia
Romania
Hungary
Bulgaria
Serbia

Western Europe
Belgium
France
Germany
Italy
The Netherlands
Spain
United Kingdom

Northern Europe
Finland
Sweden
Norway
Denmark
Lithuania
Latvia
Estonia

Biomapas is a clinical, regulatory and pharmacovigilance solution provider to the global life science industry.

Reasons to choose us:

Geographical Coverage

Covered areas are highlighted in green

North America
Canada United States

LATAM
Brazil Mexico

CIS REGION
Armenia Azerbaijan Belarus Georgia Kazakhstan Kyrgyzstan Moldova Mongolia Russia Tajikistan Turkmenistan Ukraine Uzbekistan

Western Europe
Austria Belgium France Germany Ireland Italy Luxembourg Switzerland The Netherlands Portugal Spain United Kingdom Liechtenstein

Northern Europe
Finland Sweden Norway Denmark Iceland Lithuania Latvia Estonia

Central, East and South Europe
Bulgaria Hungary Romania Poland Czech Republic Slovakia Slovenia Croatia Serbia Macedonia Montenegro Albania Malta Cyprus Greece Bosnia and Herzegovina Turkey

CIS REGION
Armenia
Azerbaijan
Belarus
Georgia
Kazakhstan
Kyrgyzstan
Moldova
Mongolia
Russia
Tajikistan
Turkmenistan
Ukraine
Uzbekistan

Western Europe
Austria
Belgium
France
Germany
Ireland
Italy
Luxembourg
Switzerland
The Netherlands
Portugal
Spain
United Kingdom
Liechtenstein

Northern Europe
Finland
Sweden
Norway
Denmark
Iceland
Lithuania
Latvia
Estonia

Central, East and South Europe
Bulgaria
Hungary
Romania
Poland
Czech Republic
Slovakia
Slovenia
Croatia
Serbia
Macedonia
Montenegro
Albania
Malta
Cyprus
Greece
Bosnia and Herzegovina
Turkey

CIS Region
Armenia
Belarus
Georgia
Moldova
Russia
Ukraine

Central and Eastern Europe
Austria
Switzerland
Czech Republic
Poland
Slovakia
Romania
Hungary
Bulgaria
Serbia

Western Europe
Belgium
France
Germany
Italy
The Netherlands
Spain
United Kingdom

Northern Europe
Finland
Sweden
Norway
Denmark
Lithuania
Latvia
Estonia