Product/Service

Regulatory Affairs

Source: Rho

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As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance.

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As the clinical development of new medical products becomes more complex, so has the route to regulatory compliance that ensures patient safety and regulatory compliance. The Rho regulatory professionals offer our clients comprehensive experience in drug, biologics, and device development from the pre-investigational new drug (IND) applications to the new drug application (NDA)/biologics license application (BLA) submission phase. Rho’s mission is to deliver quality services to the client in compliance with good clinical practices (GCPs) and applicable federal regulations.

Rho provides a professional, personalized approach to our regulatory consulting services, management, submissions, and clinical study document review. Rho’s established standard operating procedures assure adherence to GCPs and federal regulatory guidance standards.

We are experienced in managing, writing, reviewing, and compiling regulatory dossiers including:

  • Pre-IND, end of Phase I/II and pre-NDA briefing packages
    • Pre-investigational device exemption (IDE) briefing packages
    • Investigational new drug applications
    • Investigational device exemptions applications
  • New drug applications
  • Investigational NDAs
  • Supplemental NDAs
  • Abbreviated NDAs
  • BLAs
    • Premarket notification applications (510(k))
    • Premarket approval applications (PMA)
    • Investigational medicinal product dossiers (IMPD-EU)
    • Clinical trial applications (CTA-HC)

 

We are also experienced in writing and reviewing regulatory documents including:

  • Investigational brochures
  • Clinical development plans
  • Informed consent documents

 

Our extensive experience managing communication with institutional review boards, the FDA, and other regulatory authorities enables clients to work more effectively, while reducing time to market and conserving patent life. Whether we are providing expert advice, planning meetings, preparing pre-meeting briefing packages, or facilitating communication between the sponsor and the FDA or other regulatory authorities, Rho’s regulatory professionals guide sponsors through each step of the process.

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