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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

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Facility Registration & Listing

SET UP SHOP

How and where your product is produced is critical to efficacy, reliability and safety. Our specialists can guide you through facility registration and listing by identifying existing and/or qualifying manufacturing facilities, and consulting on facility design, construction, system adaptation, and acceptance testing of equipment.

Our team’s capabilities include: assessments of engineering plans, sterilization, laboratory standards, HVAC and environmental controls, dust control systems, processing.

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