Marketing Applications

Source: Rho
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Setting the highest standards for marketing applications
A marketing application is the most critical milestone in your clinical research program. Quality applications can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life – demanding a partner with an insider’s understanding of the regulatory landscape and a proven track record for success.

At Rho, each marketing application we support reflects the collaboration of our integrated, cross-functional team of regulatory affairs, clinical operations, data standards, regulatory and medical writing, project management, clinical data management, biostatistics, and programming experts. And with a 100% technical acceptance rate with the FDA, you can be sure that the quality that drives all of our services is reflected in each of our submissions to regulatory authorities.

Informed by experience, driven by process

Rho’s dedicated regulatory strategy and submissions team is led by experts who have collectively been instrumental in supporting more than 70 marketing applications throughout their careers, including 30 at Rho in the last 5 years. Rho’s experts each bring more than 20 years of experience in clinical research, product development, data standards, quality assurance, and regulatory affairs.

Rho’s expert team provides a wide spectrum of support for regulatory marketing application dossiers, submissions, and meeting deliverables. This support includes:

  • Regulatory authority meeting attendance and briefing packages
  • US Marketing Applications: NDA/BLA/PMA
  • International Marketing Applications: MAA/JNDA/NDS
  • Annual Reports/DSURs/PSURs
  • PSPs/PIPs
  • Orphan Designation Applications
  • Expedited Development Program Submissions, including Breakthrough Designation Applications, Fast Track Applications, and RMA

Our biostatisticians and data standards experts, who are an integrated part of our regulatory strategy and submissions team, are extremely well-versed in the regulatory requirements for data collection and presentation to regulatory authorities, such as FDA and PMDA. Consequently, our experts are called upon frequently to assist with the following components of FDA submissions and other regulatory submissions:

  • Compound analysis databases
  • Study analysis databases
  • Domain databases
  • CDISC SDTM and ADaM implementation
  • Define.xml files and study data reviewer guides
  • Integrated data sets (for ISE and ISS)
  • Integrated clinical and statistical analysis plans
  • Exploratory analyses

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