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, Clinical Operations, Data Standards, Regulatory and 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 document templates, data tools and programs, and processes to produce compliant regulatory submission documentation, reports, and dossiers. We ensure that the quality that drives all of our services is reflected in all of our submissions to regulatory authorities such as FDA and EMA.

Regulatory submissions informed by experience, driven by process

Rho's dedicated regulatory strategy and submissions team is led by professionals with over 20 years of experience in clinical research, product development, data standards, quality assurance, and regulatory affairs. We can support numerous kinds of regulatory authority submission deliverables, including the following:

  • Regulatory Authority Meeting Briefing Packages
  • NDAs/BLAs/MAAs (including 505(b)(1), 505(b)(2), 351(a), and 351(k) applications)
  • Annual Reports/DSURs/PSURs
  • PSPs/PIPs
  • Orphan Designation Applications
  • Breakthrough Designation Applications

PDFClick here to download information about our orphan drug experience.


Our biostatisticians and data standards experts, who are an integrated part of our overall 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 EMA, and, consequently, we 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
  • 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 Operations
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.

Regulatory and 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 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, whether they be clinical, regulatory, or statistically focused, or interdisciplinary end to end product development programs.

See our experience with regulatory submissions

RegulatorySlickSheet-2019-compressed.pdf Download File ›