About Our Company
About Kruse Consulting Group Kruse Consulting has a proven record of being able to identify the value of development projects including the assessment of development strategies, regulatory implications and the probability of technical success. The ability to find means of meeting project and company targets using existing resources is one of our strengths.

Mission Statement

KRUSE CONSULTING GROUP is committed to assisting clients in creating competitive, multinational development plans, approvable regulatory dossiers and comprehensive chemistry, manufacturing and control sections. With over 30 years experience in the pharmaceutical industry, Kruse Consulting Group® provides a full spectrum of PROFESSIONAL SERVICES to meet client needs.

More about Carolyn Hoskins Kruse, Founder

Pharmaceuticals

Project Collaboration & Key Contacts
TLI Development
Primary Services
  • Development of regulatory strategies and development plans
  • US Agent for US and ex-US firms
  • Preparation of submissions to FDA, the European Regulatory Authorities and the EMEA
  • Preparation for meetings with regulatory authorities
  • Conduct of GMP and data integrity audits
  • QA of scientific reports and technical dossiers
Areas of Expertise
  • International and US Regulatory Affairs
  • Pharmaceutical Development and Technology Transfer
  • Multinational Project Management
  • Training in the Drug Development and Approval Process