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Insights & Resources For Life Sciences Professionals.

Whether you’re a healthcare professional, a researcher, or simply interested in the drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!

Pharmacovigilance & Medical Information
Clinical Research
Regulatory Affairs
What is Medical information and Communication?

What is Medical information and Communication?

Sep 9, 2021

It is no secret that the evolution of evidence-based medicine and shared decision-making, and novel technologies have transformed how we share information and interact with Healthcare Professionals and Patients. The advances in automation, digitization, real-world evidence & Big Data analysis...

Pharmacovigilance: latest news, trends, and insights

Pharmacovigilance: latest news, trends, and insights

Jul 2, 2021

During the last years, there has been a skyrocketing demand for pharmacovigilance as medicinal products consumption is growing and disorders and diseases are becoming more prevalent. To top this, an increasing number of adverse drug reactions (ADRs) is becoming a significant concern leading to the...

Setting Up A Pharmacovigilance System

Setting Up A Pharmacovigilance System

Jul 1, 2021

Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product's Market Authorization Application (MAA). A robust pharmacovigilance (PV) system consists of a safety...

Advantages of QPPV Outsourcing in the EU/EEA

Advantages of QPPV Outsourcing in the EU/EEA

Jun 1, 2021

Advantages of QPPV Outsourcing in the EU/EEA Pharmaceutical companies with a primary base outside the EU, companies without in-house PV capabilities or companies with business decisions to refocus their workload on core strategic competencies often look to externalize these crucial activities....

What are the advantages of a hospital-based Early Phase Unit?

What are the advantages of a hospital-based Early Phase Unit?

Jan 10, 2022

Choosing the right setting for your early phase trial can be challenging. As a sponsor, it's natural to remain cautious about running more extensive early-phase patient trials in a single Phase I unit due predominantly to the doubt over actually being able to recruit large patient populations....

Biomapas joins SwedenBIO organization

Biomapas joins SwedenBIO organization

Dec 2, 2021

December 2021 Biomapas has joined the SwedenBIO organization starting November 2021. Joining SwedenBIO's mission to promote an environment bringing success and growth to the entire Swedish life science industry, we seek to walk the path in developing the life sciences sector. "Having participated...

What are the Challenges of Decentralized Clinical Trials?

What are the Challenges of Decentralized Clinical Trials?

Nov 16, 2021

The COVID-19 pandemic has accelerated the adoption of decentralized clinical trials by emphasizing the tangible advantages of virtual trials and their ability to improve the patient and physician experience. Moreover, it requires stakeholders to devote time and resources before reaping the...

Challenges In Early Phase Oncology Trials

Challenges In Early Phase Oncology Trials

Oct 18, 2021

Cancer is the biggest cause of mortality globally, with 19.3 million new cases and over 10 million deaths expected in 2020. By 2040, the worldwide cancer burden is predicted to reach 28.4 million cases. Female breast cancer is the most often diagnosed type of cancer, followed by lung, colorectal,...

What is the Clinical Trials Regulation?

What is the Clinical Trials Regulation?

Oct 14, 2021

The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the EU.  By bringing all...

Expediting access through Reliance Pathways: MENA region

Expediting access through Reliance Pathways: MENA region

Mar 16, 2021

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 (MENA) region have implemented the Abridged and Verification reviews. These regulatory procedures allow the approvement of needed innovative and/or life-saving drugs.

Medical Device Registration in Russia. Challenges and Issues

Medical Device Registration in Russia. Challenges and Issues

Mar 15, 2021

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: 1. The specificity of...

eCTD Submission Strategies: In-house vs. Outsourcing

eCTD Submission Strategies: In-house vs. Outsourcing

Mar 13, 2021

Webinar: eCTD Submission Different Strategies: In-house vs. Outsourcing eCTD Submission Strategies, including outsourcing, are influenced by varying requirements in various regions and countries. That and diverse technical resources by companies often lead to various regulatory strategies. Thus,...

Drugs serialization and barcoding in Saudi Arabia and MENA region

Drugs serialization and barcoding in Saudi Arabia and MENA region

Mar 11, 2021

  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 pharmaceutical companies...

eCTD implementation across MENA region: What is the current status?

eCTD implementation across MENA region: What is the current status?

Mar 11, 2021

As the electronic Common Technical Document (eCTD) became the standard for submitting Regulatory Information to leading agencies worldwide, its adoption still poses a considerable challenge for those agencies who lack the needed human and/or material resources. How is the situation in the Middle...

Building Health Literacy: The Value of Good Writing

Building Health Literacy: The Value of Good Writing

Oct 21, 2020

Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.

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Discover the tailored solutions that Biomapas provides to accelerate your clinical trials and optimize your drug development process.
Affiliate-Based Outsourcing
CSV For Pharmacovigilance Systems
Early Phase Oncology
Functional Service Provision
M&A Support

Clinical Research

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Regulatory Affairs

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Pharmacovigilance

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Medical Information

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