• Careers
  • About Us
  • Academy
  • Events
  • Insights
  • Contact Us
  • Submit RFI/RFP
Biomapas
  • Clinical Research
  • Regulatory Affairs
  • Pharmacovigilance
  • Medical Information
Select Page
Marketing Authorization Renewal in the MENA Region

Marketing Authorization Renewal in the MENA Region

by Kamile Gruduls | Jul 30, 2021 | Regulatory Affairs

Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization Approval certificate of pharmaceutical products that ranges between four to five years in most countries. The purpose behind this license validity period...
Company Registration Requirements in MENA: a Prerequisite for Product Registration

Company Registration Requirements in MENA: a Prerequisite for Product Registration

by Kamile Gruduls | May 12, 2021 | Regulatory Affairs

Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture.  MENA countries are accepting...
Biosimilars in the MENA Region: Regulatory Landscape

Biosimilars in the MENA Region: Regulatory Landscape

by Kamile Gruduls | Apr 27, 2021 | Regulatory Affairs

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...
Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

by Nick | Mar 16, 2021 | Regulatory Affairs

Reliance models are review pathways used by Regulators to expedite the patient access to essential pharmaceutical products and to overcome resource constraints and priorities.   Recently, several National Competent Authorities (NCA) in the Middle East North Africa...
Drugs serialization and barcoding in Saudi Arabia and MENA region

Drugs serialization and barcoding in Saudi Arabia and MENA region

by Nick | Mar 11, 2021 | Regulatory Affairs

  An increasing number of countries worldwide have enacted regulations mandating serialization, tracking and tracing of pharmaceutical products down the supply chain during recent years as a response to drug integrity concerns. There are plenty of laws requiring...
« Older Entries

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)

K. Donelaicio str. 60

LT-44248 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
  • Marketing Authorization Applications (EU / EMA)
  • 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 Monitoring
  • 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 All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Manage CookiesAccept all
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