RIO PHARMACEUTICAL SERVICES
MEDICAL & REGULATORY CONSULTING 

                       

Services

  • Briefing packages
    • from pre-IND to pre-NDA (drugs)
    • from pre-IDE to pre-PMA or 510k (devices)
    • pre-PLA/BLA (biologics)
  • Preparation of regulatory applications and filings, including NDAs, 510ks, PMAs & PLAs/BLAs
  • Strategic documents for internal decision-making, including white papers.
  • New-product and marketing-materials evaluations
  • Report writing for all clinical-trial phases, including drug pharmacokinetics

  • Clinical study design and protocol preparation
  • Interfacing with regulatory agencies and authorities
  • Preparatory meetings, including:
    • identification and procurement of key opinion leaders (KOLs)
    • Organization of KOL meetings and drafting of position papers
    • Organization and assembly of agenda and issue-related documents
    • Implementation and facilitation of issue discussion and consensus/resolution
  • Expert panel meetings to prepare for advisory committee presentations
  • Liaise with small/medium companies, both within and outside the U.S., to address their specific drug-development needs, including FDA representation.

       

RIO PHARMACEUTICAL SERVICES 
135 Walter's Brook Drive
Bridgewater, NJ 08807-5633
 (908) 672-6388
eve@riopharma.com