Regulatory Affairs

Whether you need assistance with submissions, with regulatory filings, or with crafting language appropriate to specific pharmaceuticals, substances or devices, Compliance Insight has the depth of knowledge to advance the approval process through the FDA’s regulatory process.

Our team provides an array of services, from training to preclinical evaluations to meeting reporting deadlines. We deliver world-class service, and will be an impactful strategic partner in new product launches and throughout your product’s development cycle.

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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