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Project Orbis: How Trans-Jurisdiction Review Is Accelerating Global Product Launches

Project Orbis is a great opportunity for enhanced collaboration between regulatory agencies across the world which has resulted in substantially expeditious approvals of medicines.

| Articles, Homepage News, Oncology, Regulatory Affairs

The Road to Pharmacovigilance Outsourcing Guidance

Looking for Pharmacovigilance support? Learn how to make the process as easy as possible with these step by step guidelines to outsourcing pharmacovigilance services.

| Articles, Homepage News, Pharmacovigilance, Regulatory Affairs

Expedited Reviews: What you need to know to be Successful

This case study is an excellent example of how a well-planned and meticulously executed regulatory strategy can lead to a collaborative and rapid review

| Articles, Homepage News, News, Regulatory Affairs, Services News

Expedited Reviews: What you need to know to be successful

Throughout the drug development process there are many factors influencing speed to market but none more visible and critical than an expedited regulatory review.

| Homepage News, Regulatory Affairs

The challenges to overcome age-related disease

In this article, Tom Hughes and Johan Strömquist discuss the challenges facing longevity research and the adoption of health span as a viable target for medicines in the future.

| Articles, Homepage News, News, Regulatory Advisory Board, Services News

Enhancing Pharmacovigilance

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.

| Articles, Homepage News, News, Oncology, Pharmacovigilance, Regulatory Advisory Board, Services News

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

In this white paper, NDA's Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.

| Articles, Homepage News, Leadership Team, News, Regulatory Advisory Board, Regulatory Affairs, White Papers

What did we learn from the 2009 pandemic?

In this commentary, NDA's Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.

| Advisory Services, Articles, Homepage News, Infections and Infectious diseases, News, Regulatory Advisory Board, Vaccines

Medical Devices and their growing regulatory challenges

In this article, NDA's Tina Amini explains what companies need to look out for in the growing area of device regulation.

| Articles, Homepage News, News, Services News

Global capabilities for local growth

In this commentary, NDA's Johan Strömquist and Thomas Lönngren provide their reflections on the unique opportunities the Nordics present for the Life Science sector.

| Articles, Events & Presentations, Homepage News, Leadership Team, News, Social News

Prime - The European approach to expedited pathways

In this white paper, Steffen and Eva discuss the different tools available to European regulators and the experiences so far with the PRIME pathway.

| Articles, Homepage News, News, Pre-submission, Regulatory Advisory Board, White Papers

European Regulatory Meetings - how best to prepare and perform

In this article, NDA's Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.

| Articles, High-stakes Meeting Preparation, Homepage News, News, Regulatory Advisory Board

Importance of Excellence in Scientific and regulatory Communication

In this white paper, PharmApprove's Lisa Peluso discusses how  excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.

| Articles, High-stakes Meeting Preparation, Homepage News, News, Pharmapprove, White Papers

Why should you engage early with regulators and HTA bodies?

NDA’s Dr Mira Pavlovic-Ganascia and Claes Buxfeldt provide insight on what the expected outcomes of constructively engaging with regulators and HTA bodies could be.

| Articles, Health Technology Assessment, Homepage News, News, White Papers

4 ways that HTA will change under the new European regulation

In this white paper NDA's CEO, Johan Strömquist, discusses four ways that Health Technology Assessments will change under the new proposed European regulation.

| Articles, Health Technology Assessment, Homepage News, News, White Papers

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