R. P.Chiacchierini & Associates, LLC

Statistical and Regulatory Consulting

R.P. Chiacchierini & Associates

To find out more about our company, personnel, and services, please see the pages below.

Home

Principals:
Richard P. Chiacchierini
Richard E. Lippman

Services:
Biostatistical Services
Device Regulatory Affairs
Quality Systems & Compliance
Biologics Regulatory Affairs

R. P. Chiacchierini & Associates, with support from affiliated consultants, provides a broad range of regulatory and clinical consulting services to companies who are involved with or manufacture biologic products.

These services include:

  • Strategic product development and regulatory planning
  • Protocol development and implementation
  • Assistance in Regulatory submissions [IND, ELA/PLA, BLA, IDE, PMA, and 510(k)]
  • Strategy development and implementation
  • Document and submission preparation
  • FDA meeting coordination, preparation and assistance