Prepare To Win

You’ll encounter numerous regulatory, scientific and communication challenges on your journey from development to commercialization. When the stakes are highest – at an FDA Advisory Committee or a CHMP Oral Explanation – we guide you to success.

Learn More

150+

Advisory Committee clients

100+

Oral Explanations

85%

Advisory Committee success rate

What we do

No matter where you are in development, our team of multidisciplinary experts prepare you for successful interactions with regulators and key decision-makers.

For 20 years we’ve been driving better decisions for our clients by transforming cutting-edge science into compelling communications. We align all levels of management and empower teams to communicate persuasively at critical milestone meetings with FDA, EMA and other health authorities.

Who we are

PharmApprove is an integral part of NDA Group – an international consultancy excelling in scientific communications, regulatory science and drug development.

The combination of our resources offers biopharmaceutical companies an unparalleled breadth and depth of global experience and expertise. We integrate science, regulatory and communications strategies to promote the rapid development of novel therapies. We have been the leaders in Advisory Committee meetings and Oral Explanations in the US and Europe for over 20 years.

There is everyone else and then there is PharmApprove.

Why choose us

Worldmap-Pharmapprove-e1585434059595

We are former executives from industry, leaders of regulatory bodies, and communications experts with our fingers on the pulse of global drug development and regulatory science. From our past successes we are helping shape the future.

We have the broadest expertise in US and European regulatory approval processes to support you from development to commercialization. Combine this with our proven methods, technology and infectious winning attitudes and you’ll understand why people say, “There’s everyone else and then there’s PharmApprove.”

Learn More

PharmApprove drives internal alignment to streamline readiness, and coaches you to succeed at every step along the regulatory path – and beyond.

Learn More

Our Experience

For 20 years we’ve helped innovative life science companies prepare to win at high profile, high stakes meetings such as Advisory Committees, Oral Explanations, expert panels and advisory boards. We’ve coached thousands of professionals and led more than 250 clients through critical junctures to successful outcomes.

Zogenix
Theravance
Teva-Pharmapprove-Client
Targanta
Tar-Pharmapprove-Client
Solvay
Takeda
Prometheus
Otsuka-Pharmapprove-Client
Organogenesis
Orexigen
Onyx
Oceana
MGI-Pharma
InterMune
Helsinn
HRA-Pharma
Genzyme
Eisai
DOR
Dura-Med
Cytyc
cti
Coronado
Cornerstone
Columbia-Laboratories
Chem-Genex-Pharmapprove-Client
Chelasea-Terapeutics
Boehringer-Pharmapprove-Client
BioMarin-Pharmapprove-Client
abbvie-Pharmapprove-Client
Abbott
Contact us

We are ready to help you