“Pacific Pharma Group offers efficient product development through thoughtful design.”

Services
Protocol Writing
Product Development Strategy
Medical Monitoring
Data Safety Monitoring Board

Areas of Expertise
Japanese Bridging Studies
First Time In Humans
Microdose Studies
Biologics
Nutraceuticals
Asian Population Studies
Special Patient Populations

 

 

Welcome to Pacific Pharma Group

Pacific Pharma Group, LLC, is a “niche” consulting company focused on increasing the efficiency of global product development, especially through the early development phases. The Principal, Jon L. Ruckle, MD, and other consultants bring years of experience across a wide range of products, clinical domains, and clients ranging from large Pharma to start up companies with a single product. Whether your product development plans resembles a ‘sketch on the back of a napkin’, or you are seeking guidance for specific questions, we are prepared to help. Areas of particular interest include:
First Time In Humans studies, including biologics

  • Early development strategies, from IND through proof of concept
  • The role of an exploratory IND and microdose studies
  • “Bridging” studies for registration in Japan
  • Healthy elderly, pediatrics, and special patient populations
  • Global development strategies, especially involving Asia