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

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

Claes Buxfeldt and Paula Salmikangas discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.

Claes Buxfeldt discusses key considerations in early development to succeed with market access for immune-oncology products in the EU.

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.

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.

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

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

We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.

There is no doubt that the area of oncology development has exploded in the last few years.

What makes NDAs new General Manager for the Nordics, Robert Kronqvist, tick?

Earlier this year the 2nd International Alliance of Biological Science meeting was held to review the status of the current knowledge regarding the relationship between narcolepsy and the administration of the adjuvanted pandemic influenza vaccines.