SERVICES

We provide Information, training and guidance relating to the regulation of human and animal foods, drugs, medical devices, biologics, as well as, dietary supplements and cosmetics.

 

INFORMATION

  • Current agency policies

  • Laws and regulations

 

TRAINING AND GUIDANCE

Can provide training customized to your needs including:

  • Good Manufacturing Practices for foods, dietary supplements, drugs, medical devices, and biologics laws enforced by FDA.

  • How to prepare for, and respond to, an FDA inspection.

  • Mock inspections.

  • The recall and corrective action process and requirements.

 

REVIEW PROCESSES

  • Review of responses to:

    • Inspectional findings (483s)

    • FDA Mock Audits

    • Untitled letters

    • Warning letters

    • Regulatory meetings and other regulatory actions.

  • Oversight of your firm’s response to regulatory actions.

  • Create a regulatory strategy for maintaining compliance activities.

  • Give guidance to bring your firm into compliance with FDA law and regulations

  • Review labels (including websites) and promotional materials.

  • Review of the firm’s standard operating procedures.

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Tianjin, China

Karnataka, India

Denver, CO, USA

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Toluca, Mexico