Manresa FDA Consulting, LLC

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.