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PROMETRIKA’s portfolio of services includes extensive work in New Drug Applications (NDAs) and Marketing Authorisation Applications (MAAs). In the company’s 16 year history, PROMETRIKA team members have collaborated on 19 NDAs and MAAs. Our data managers, statistical programmers, biostatisticians, and medical writers have designed, implemented, and reported on the clinical submission data in indications such as oncology, CNS/psychiatry, renal disease, respiratory disease/allergy, and several rare diseases. PROMETRIKA’s NDA/MAA Project Managers (PMs) have developed the tools and skills necessary to successfully manage the study level team and the subject matter experts to complete submission projects with high-quality, on-time deliverables.