Regulatory submissions

Providing the highest standards for submissions

Regulatory submissions are the most critical milestones in your clinical research program. Quality submissions can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and conserve patent life.

At Rho, each deliverable reflects the collaboration of our interdisciplinary team of Regulatory Affairs, Data Standards, Medical Writing, Project Management, Clinical Data Management, Biostatistics, and Programming staff. From early-phase development through life cycle management, we use a standardized library of data tools, programs, and processes to produce regulatory submission documentation, reports, and dossiers. We ensure that the quality that drives all of our services is reflected in the investigational new drug (IND), new drug application (NDA), supplemental new drug application (sNDA), common technical document (CTD), and other submissions we prepare for and with our clients.

Regulatory submissions informed by experience, driven by process

The Rho regulatory team is led by professionals with over 20 years of experience in clinical research, product development, data standards, quality assurance, and regulatory affairs. We have completed numerous kinds of submissions, including INDs, clinical trial authorizations (CTAs), investigational medicinal product dossiers (IMPDs), and end-of-Phase II (EOP2) submissions. We understand the environment under which policies and practices evolve at the FDA and the European Medicines Agency (EMEA). Our vast experience and focus on quality has resulted in a 100 percent acceptance rate for submissions with the FDA.

Regulatory submissions deliverables

Documents

• Investigator brochures, study protocols, and protocol amendments
• Pre-IND and -NDA meeting briefing packages
• IND/investigational device exemption (IDE) applications and period safety updates
• Clinical study reports
• Patient narratives
• Premarket notifications 510(k)
• IMPDs, CTAs, 505(b)(2), biologic license applications (BLAs)
• Integrated summaries of safety (ISSs) and integrated summaries of efficacy (ISEs) in CTD format
• Safety updates, annual and 120-day post-submission reports

Data

• Compound analysis databases
• Study analysis databases
• Domain databases
• Clinical Data Interchange Standards Consortium (CDISC) (Study Data Tabulation Model [SDTM] and Analysis Data Model [ADaM]) databases
• Define files (PDF or XML), Readme file
• Integrated data sets (for ISE and ISS)
• Integrated clinical and statistical analysis plans
• Exploratory analyses

Submissions capabilities

Our sponsors' regulatory submissions benefit from professional expertise across our entire company.

Regulatory Affairs

Our experienced regulatory team understands that you get one chance at a submission and ensures that all deliverables meet regulatory guidance standards.

Data Standards

Rho is a leader in development and implementation of CDISC standards. Learn about how our professionals deliver results to the highest data standards and how we can enhance your clinical trial program.

Medical Writing

Rho's Medical Writers are experienced in delivering protocols, investigational brochures, clinical study reports, and documents for IND and NDA submissions.

Biostatistics and Statistical Programming

Our statisticians have vast experience with the common safety endpoints and can tackle the challenges of integrated analyses (ISS and ISE) for numerous therapeutic areas. We provide documentation of statistical methods and results that will impress even the most skeptical of FDA reviewers.

Project Management

Learn about Rho’s project process and how our project management professionals will see to it that your project is completed as efficiently as possible.

If you don’t see exactly what you’re looking for, click here to discover Rho’s comprehensive list of full-service capabilities.