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FDA Compliance

Compliance Insight specializes in helping businesses in the pharmaceutical medical device, and biologic industries navigate the FDA regulatory process. We offer an extensive suite of capabilities, and are able to develop impactful strategic plans that bring products to market quickly and efficiently.

Our expert network of consultants posses a deep knowledge of FDA practices. We have helped hundreds of life science professionals achieve and maintain FDA compliance, and routinely address needs that include: product submission, GXP training, clinical and nonclinical development, program design, product evaluation, and system monitoring.

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

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