Proven Quality and Compliance Solutions for Life Sciences

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PHARMACEUTICAL | MEDICAL DEVICE | BIOLOGICS INSIGHTS

PHARMACEUTICALS

MEDICAL DEVICE

BIOLOGICS

avoid FDA waring letters

COMBO REPORTS

Pharmaceutical, Medical Device, And Biologics Manufacturing Companies Must Ensure Compliance With FDA Regulations To Avoid Warning Letters And 483s

Navigate FDA Compliance with Precision: ComplyFDA’s Expert Remediation Services

Secure your pharmaceutical or medical device manufacturing processes with ComplyFDA’s premier FDA warning letter remediation services. Specializing in the rigorous demands of the healthcare sector, our team offers unparalleled expertise in FDA inspection readiness, meticulous quality system audits, and comprehensive regulatory documentation support.

At ComplyFDA, we leverage deep industry knowledge across pharmaceuticals, medical devices, and biologics. Our professionals are not only well-versed in current Good Manufacturing Practices (cGMP) and Quality System Regulation (QSR), but they also bring a proactive approach to each compliance challenge. Partner with us to enhance your compliance strategies, minimize the risk of non-compliance, and protect your company from costly repercussions, including warning letters and Form 483s. Trust ComplyFDA to guide you through the complexities of FDA regulations with expert precision, safeguarding your reputation and ensuring continuous compliance.

Professional Services

  • FDA Inspection Readiness
  • Manufacturing and Production Processes
  • Pharmaceuticals
  • Medical Device
  • Combination Products
  • Contract Manufacturing
  • Biologics
  • Dietary Supplements
  • Automated Production Processes and Controls

  • Production and Process Controls
  • Packaging and Labeling
  • Complaint Files
  • Records and Reports
  • Laboratory Controls, Measurement and Inspection
  • Out of Specification/Failure Investigation
  • Nonconforming Product
  • Corrective and Preventive Actions

  • Detailed Data Monitoring
  • Reports and Visualizations
  • Compliance Risk Evaluation
  • Quality and Compliance Training

  • Cleanroom Validation
  • Manual, Semi-Automated, Fully Automated Equipment
  • IT Systems – Automation Controls, Vision Systems, Production, Packaging and Labeling
  • Inspection and Test Method Validation
  • Packaging and Labeling Equipment
  • Process Monitoring and Reporting Systems

  • Plans for Quality Systems, Clinical Research, Design Controls
  • Designed to Improve Overall Process Performance and Efficiency
  • Reduce Regulatory Risk

  • Highly Collaborative, Team Approach
  • Validated Industry Best Practices
  • Objective, Data Based Assessment Methodology
  • Deliver Sustained Performance Improvement of Quality Processes

  • Manual and Automated Measurement Systems
  • Measurement System Validation
  • Impact of Human Performance
  • Calibration and Maintenance
  • Data Transfer, Backup and Storage

  • Production and Process Controls
  • Product Design and Development
  • Use of Artificial Intelligence and Machine Learning
  • Integration of Risk Criteria into Operating Procedures
  • Risk/Impact Assessment of Failures and/or Excursions

Pharmaceutical, Medical Device and Biologic Visualizations

The sample Biologics/Supplement visualization is for reference only.
Similar and expanded visualizations for Pharmaceuticals and Medical Devices are available upon request.

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