• Careers
  • About Us
  • Academy
  • Events
  • Insights
  • Contact Us
  • Submit RFI/RFP
Biomapas
  • Clinical Research
  • Regulatory Affairs
  • Pharmacovigilance
  • Medical Information
Select Page
Must-Know Legislation for Medical Device Registration in the EAEU

Must-Know Legislation for Medical Device Registration in the EAEU

by Kamile Gruduls | Jun 17, 2021 | Regulatory Affairs

EAEU legislation for Medical Device registration has been continuously updating for the last six years since the Eurasian Economic Union, otherwise known as EAEU, was entered into force in 2015. Five countries have signed the “Treaty on the Eurasian Economic...
Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

by Nick | Jun 9, 2021 | Webinar

Join the webinar: Medical Device Registration in the Eurasian Economic Union (EAEU) The webinar on Medical Device Registration in the Eurasian Economic Union (EAEU) reviews the practical aspects of the approval procedure. We will discuss the various stages of the...
Successful Medical Device Registration in EAEU: New Legislation (Part 1)

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

by Nick | Apr 2, 2021 | Regulatory Affairs, Webinar

Watch the on-demand webinar replay: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and...
Medical Device Registration in Russia. The Essentials

Medical Device Registration in Russia. The Essentials

by Kamile Gruduls | Mar 17, 2021 | Regulatory Affairs, Webinar

Webinar: Successful Medical Device Registration in Russia. The Essentials The current national system for Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling – some...
Medical Device Registration in Russia. Challenges and Issues

Medical Device Registration in Russia. Challenges and Issues

by Kamile Gruduls | Mar 15, 2021 | Uncategorized

Webinar: Medical Device Registration in Russia. Challenges and Issues The purpose of this webinar is to show the differences and specifics of regulations and law processes that can cause challenges in medical device registration in Russia.   You will learn about:...

Copyright © 2021. All rights reserved. 

Privacy Policy

EU Funding

  • Follow
  • Follow

Lifecycle Stage

  • Development
  • Marketing Authorization
  • Post-Authorization

Solutions

  • Clinical Research
  • Regulatory Affairs
  • Pharmacovigilance
  • Medical Information

Contact

T +37(0)37366307

E info@biomapas.com

Address (HQ)

109 Savanoriu Ave.

LT-44208 Kaunas

Lithuania

About Biomapas

A complete spectrum of Clinical Research, Regulatory Affairs, Pharmacovigilance, and Medical Information services across Europe, the CIS/EAEU, and MENA regions.

Functioning as a seamless extension of your team, we act globally and have local expertise.

Early Phase Unit

Clinical Development

Functional Service
Provision

  • Early Phase Unit
  • Healthy Volunteer Studies
  • Patient Studies
  • Early Phase Studies
  • Phase II – III
  • Rescue Studies
  • Study Design and Protocol Development
  • Strategic Feasibility
  • Regulatory and Ethics Committee Submissions
  • Project Management
  • Clinical Monitoring and Site Management
  • Clinical Safety & Pharmacovigilance
  • Medical Monitoring
  • Quality & Compliance
  • Legal & GDPR Representation
Early Phase Unit
Therapeutic Expertise

Pre-Authorization

Marketing Authorization

Post-Authorization

  • Regulatory Strategy and Dossier GAP Analysis
  • Scientific Advice
  • Dossier Development / Medical Writing
  • Chemistry, Manufacturing & Controls
  • Medical Devices & IVD
  • Marketing Authorization Applications (EU / EMA)
  • Local Regulatory Affairs Support EAEU/CIS Region
  • National Marketing Authorization Applications
  • eCTD & NeeS Compilation
  • Promotional Material
  • Regulatory Intelligence
  • Local Regulatory Affairs Support EAEU/CIS Region
  • Medicinal Product Lifecycle Management
Geographic Coverage
Medical Devices & IVD

Clinical Trials

PV System & QPPV

Post-Authorization

  • Clinical Safety
  • Medical Monitoring
  • Pharmacovigilance System Set-Up & QPPV
  • PSMF Development & Maintenance
  • RMP Development & Maintenance
  • EAEU-QPPV
  • Pharmacovigilance Database
  • Pharmacovigilance Audits
  • Local Pharmacovigilance Representation
  • Global and Local Literature Screening
Geographic Coverage
Veeva Safety Database

Medical Inquiry Intake & Management

Medical Writing

Quality Management

  • Multilingual Call Handling Service
  • Medical Inquiry Management system​
  • Global Query Handling
  • Local Query Handling
  • Adverse event, Product Quality Complaint Intake & Handling
  • After Hour Services
  • Standard Documents Creation
  • Custom Response & Content Management
  • Translation Services
  • SOP Creation
  • Key Performce Indicators & Metrics
  • Integrated Compliance Monitoring
Geographical Coverage
Integrated Technology
We value your privacy.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of cookies.
Accept Cookies
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled

Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.

CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.

Functional

Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.

Performance

Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.

Analytics

Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.

Advertisement

Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.

Others

Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.

SAVE & ACCEPT
Powered by CookieYes Logo