NDA and PharmApprove Logos
Pharmapprove – Overview…

Unmatched expertise…

NDA Group and PharmApprove have merged to become the world’s leading drug development consultancy, offering solutions to create and evaluate product development plans and communicate the scientific results to regulatory, advisory and payer audiences. Our mission is to streamline the global development and commercialization process to accelerate patient access to important medical therapies.

Over the past three years NDA supported over 45% of new medicinal products approved in the EU, while PharmApprove’s success rate for FDA Advisory Committee meetings topped 85%. Together we are now building on this successful track record to offer streamlined, strategic drug development advice across the world’s two largest markets.

For our clients this means access to a single strategic partner with an unmatched, world class team and a network of over 1000 key opinion leaders, former regulators and subject matter experts. Our comprehensive expertise will help forge a clear development path, encompassing both regulatory and market access requirements to minimize time to market, and maximize the probability of success across a therapy’s life cycle.

Press Release

How we can help...

We integrate scientific, regulatory, communications and reimbursement strategies to:      

       
Case Studies...
  • Clinical Development Program

    Successful global Phase 3 development program to meet US and EU regulatory needs.
    Download Case Study


  • Parallel US/EU Submissions

    Global gap analysis and risk mitigation to support EU and US submissions.
    Download Case Study


  • Payer Negotiation and Training

    Payer negotiation training of client affiliates, including communications workshop and “mock payer panel” to test defense of PVP, handling objections and obtaining optimal outcomes.
    Download Case Study


Events...
Contacts...

  • Olga Björklund

    Senior Regulatory Consultant, NDA Group

    E. info@ndareg.com
    T. +46 (0) 8 590 778 00



  • Cathleen McNulty

    Executive Director, Business Operations, PharmApprove

    E. info@pharmapprove.com
    T. +1 609 583 1990