White papers

Download a complimentary white paper written by a FMD K&L professional
  • Preparing FDA Submission Data Packages

    Dhiren Patel

    Yuguang Zhao

    M.S., Senior Vice President, Programming and Development

    Tiepu Liu

    M.D., Ph.D., President, Global Biometrics

    The implementation of electronic data standards advances FDA efforts by enabling more timely and effective regulatory reviews of submissions and their corresponding data. This white paper describes the evolution of relevant standards and provides recommendations for best practices in planning and preparing FDA submission data packages.


  • Strategies for a Successful Rx-to-OTC Switch


    Dhiren Patel

    Munendra Kumar

    M. Pharm, Global Head – Regulatory

    Dhiren Patel

    B. Pharm, PGDBM (Business Management), Manager – Regulatory Affairs

    The Rx-to-OTC market in U.S. has grown into a $7.8 billion market. Are you ready to make the switch? This white paper discusses the Rx-to-OTC process, challenges, strategies and the roadmap for pharmaceutical companies to execute a successful switch.


  • 3 steps to outsource your drug safety program


    Alok Gokhale

    MS, MPharm, Business Analyst

    Selecting a vendor to operate your safety program can be a daunting task. This white paper provides a stepwise procedure for choosing among the hundreds of available outsourcing partners.


  • Risk Management Roadmap to REMS Success


    John D. Balian

    M.D., Board of Directors

    At the birth of the REMS era, FMD K&L Board Director John D. Balian, M.D. and colleagues outlined a vision for anticipating risk-management requirements, establishing risk-management practices, and leveraging these techniques in the effective utilization of REMS programs. Their approach to enhancing product development, approval and commercialization remains germane to optimizing safety benefits for patients to this day.