NDA Group and PharmApprove Announce Strategic Alliance


Applied Clinical Trials

Princeton, NJ and Stockholm, Sweden (June 9, 2015) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic alliance to help life science companies navigate an increasingly complex global environment. PharmApprove – a leading strategic regulatory, and scientific communications consultancy based in the US – and NDA Group – Europe’s leading regulatory, pharmacovigilance and Health Technology Assessment (HTA) consultancy – are now collaborating to provide the life science industry with truly integrated global regulatory, scientific and market access communications solutions.

“By working together, we are able to help companies get their products to market more efficiently with an optimized global label and market access position,” explained Dr. Laurie Smaldone, President and CSO, PharmApprove. “Too often companies hire one firm for US and another for EU regulatory advice and furthermore delink the planning for regulatory and market access success. This alliance offers a single partner who can provide global solutions instead of reinventing the wheel for every new market, thus saving time and money.”

PharmApprove has over 16 years of experience providing strategic and tactical support helping life science companies prepare for health authority interactions, deliver compelling regulatory and scientific arguments before US advisory committees, and making the persuasive value case to payers and HTAs. NDA Group has been at the forefront of providing strategic and operational regulatory, HTA and pharmacovigilance guidance for the last 18 years, helping more than 1,000 small and large pharmaceutical and biotech companies achieve success. 

“We recognize that all life science companies are different but fundamentally they all need the right strategic focus throughout their development programs. This is where we can add tremendous value,” said Johan Strömquist, CEO, NDA Group. “Taken together NDA Group and PharmApprove have supported life science companies for over 35 years. With the extensive experience of our former regulators, industry and communications experts we will be able to support even more companies through successful drug development programs and regulatory and HTA procedures.”

NDA Group and PharmApprove first began collaborating nearly a year ago, and already have a successful track record of working together to benefit global pharma and biotech companies. Moving forward, they plan to offer aligned services in the following areas:

1. Global integrated product development strategy, simultaneous filing support, and strategic scientific, regulatory advice through all stages of development


2. Scientific communications to help companies make the strongest, most persuasive case to regulatory and advisory audiences, both verbally and visually


3. Preparation for global milestone meetings and interactions with key decision makers

Representatives from both NDA Group and PharmApprove will be present at the upcoming 2015 BIO International Convention in Philadelphia June 15-18 and the DIA 2015 Annual Meeting in Washington, D.C. June 14-18.


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