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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

Webinar - Is an Early Development Strategy Really Needed?

Join us on 16th May at 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar with Dr Niamh Kinsella, Biologics Expert, VP, Early Stage Development.

| Homepage News, News

Effective presentation of immunogenicity related data in regulatory dossiers

NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.

| Articles, Homepage News, News, Translational Science

Free Webinar - Brexit Impact: Are you ready?

Join us on Thursday 14th February for this engaging webinar with Thomas Lönngren, Strategic Advisor and Dr Brian Edwards, Principal Consultant about Brexit impact.

| Homepage News, News, Presentations and Infographics

NDA Group expands presence in Denmark

In time for the European BIO meeting in Copenhagen NDA is expanding the physical presence in Denmark. With the appointment of Katja Gustafsson as Senior Consultant NDA will be working closely with clients in the region.

| Community News, Homepage News, News, Services News, Social News

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