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Cincinnati, Ohio 45246

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Dietary Supplement

BOOSTING CAPABILITIES

Dietary Supplements are a significant market in the consumer wellness industry, yet regulations about formulations and labeling can be challenging for manufacturers to navigate.

Our veteran consultants provide services to ensure your products meet federal standards, including ingredient assessment and label wording to ensure categorization as a supplement rather than an FDA unapproved drug.

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