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 35 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
- 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
The recent FDA approval of our innovative new therapy, AZSTARYS, is a transformational event for patients with ADHD and for KemPharm. Rho’s expertise played a role in the development program’s NDA success and their team was accountable and delivered without exception.
Andrew Barrett, CSO, KemPharm
Last year, we submitted
Kevin Barber, Ph.D.
Senior Vice President, Regulatory Strategy & Submissions
Senior Vice President, Regulatory Strategy, Biometrics & Technology
Chief Strategist, Biostatistics & Protocol Design
Brenda Faiola, Ph.D., DABT
Senior Director, Nonclinical Development
Senior Director, Statistical Programming & Data Standards
Amanda Mathis, Ph.D.
Director, Clinical Pharmacology
Genna Kingon, Ph.D., RAC
Senior Director, Regulatory Strategy
Monica Frazier, Ph.D., RAC
Director, Regulatory Strategy
Director, CMC Regulatory
Understanding New Drug Applications (NDAs)
Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will help you understand what is involved in an NDA including regulatory strategy, data integration and readiness, and electronic publishing, and provide tips that can help you avoid common pitfalls in the submissions process.Watch Webinar
David Shoemaker, Ph.D.
Senior Vice President, Research & Development