Gain Our Insight

LET'S GET STARTED

Be in Touch

 

e. info@compliance-insight.com

p. (513) 860 - 3512

© 2019 by Compliance Insight

All Rights Reserved  |  Contact Us

Corporate Headquarters

 

497 Circle Freeway Suite 230

Cincinnati, Ohio 45246

Business Hours

 

Monday - Friday 

8:30am EST - 5:30pm EST

  • facebook
  • linkedin
  • twitter
  • youtube

Quality Systems

POLICIES, PRACTICES, PROCESSES

Compliance Insight possesses the blend of scientific knowledge and industry experience needed to handle all aspects of quality assurance. Our team has more than a century’s worth of combined expertise managing risk and offers a broad range of capabilities.

We can help you design, evaluate and improve quality control systems; perform clinical material audits; develop and implement best practices plans; improve existing policies and procedures; perform trend analyses; and create plans to meet strategic benchmarks. Our goal is ensure your products can be manufactured and marketed using the safest and most cost-effective methods possible.

Experience & Capabilities

  • FDA Compliance Consulting

  • Project Management

  • FDA 483 / Warning Letter

  • Consent Decrees

  • Systems Monitoring

  • GXP Training

  • Product Submissions

  • Due Diligence

  • Product Reviews

  • Registration & Listing

  • Audits

  • Gap Analysis

  • Regulatory Strategies

  • Inspection Preparation

  • GMP Services

  • GCP Services

  • FDA Submissions

  • Clinical Development

  • Nonclinical Development
  • Risk Based Assessment

  • Combination Products

  • Staff Augmentation

  • Electronic Publishing

  • Program Design