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Regulatory authorities expand their contribution to successful drug development

NDAs Eva Lilienberg details the levels of support pharmaceutical companies can expect to receive from the authorities and how to best prepare for any agency interactions in the latest SwedenBio’s fact sheet.

| Homepage News

Regulatory strategies for value maximisation of early clinical stage assets

Prepare for partnering – Optimizing value in early development.

| Homepage News

Pdf - Seeking Parallel Consultation

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Seeking Parallel Consultation

Learn about the rationales and results of engaging early with regulators and HTA bodies in this white paper written by NDAs Dr. Mira Pavlovic-Ganascia and Claes Buxfeldt.

| Community News, Health Technology Assessment, Homepage News, Library News, News, Services News, Social News

Europe vs USA: new drug product approvals in 2017

What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug approvals in the world's two largest markets.

| Community News, Homepage News, Library News, News, Presentations and Infographics, Services News, Social News

Assessing the consequences of the EMA's relocation

The EMA is relocating to Amsterdam – but what are the consequences to the Agency’s priorities and to the industry?

| Community News, Library News, News, Services News

Revamping Regulations

| Library News, Translational Science

When the pressure is high Prepare to Win

US approvals plummeted from 45 (2015) to 19 — a drop of almost 60 percent. We have drilled down into all applications and spotted important trends that you can read about in this article were you also will find out how we can Prepare you to Win.

| Community News, High-stakes Meeting Preparation, Library News, News, Services News, White Papers

Have you ever wondered why compliance with regulations is so difficult?

What do we mean when we say ‘safety is everybody’s responsibility’? To find out more read this article written by NDAs Dr. Brian Edwards.

| Community News, Library News, News, Pharmacovigilance, Services News

Communicating with Payers

In this article you will learn about why excellence in communications is critical when it’s time to defend the value and negotiate pricing. Prepare to win.

| Community News, High-stakes Meeting Preparation, Library News, News, Services News, White Papers

Novel Drug Movers and Shakers 2013-2016

Small and medium sized companies and academia are important drivers of innovation in drug development. To investigate the profile of the organisations originating and developing novel drugs approved in the EU and US during 2013-2016 we have compiled all medicinal products containing novel substances.

| Community News, Library News, News, Services News, White Papers

Maximising value in early development

In this article written by Niamh Kinsella and Josefin-Beate Holz you will learn how you can maximise the value of your product by having an early development strategy.

| Community News, Library News, News, Translational Science, White Papers

Europe vs USA: new drug product approvals in 2016

What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug approvals in the world's two largest markets.

| Community News, Library News, News, Translational Science

Considerations for Good Pharmacovigilance Outsourcing

Read about the importance for clients and service providers to understand and discuss each other’s needs to avoid unrealistic expectations often elicited prior to signing a contract.

| Community News, News, Pharmacovigilance

New FDA Guidance: Impact on Clinical Safety Data

This article written by NDA’s Brian Edwards and Olga Björklund explains the best way to stay compliant.

| Community News, News, Pharmacovigilance

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