Proven Quality and Compliance Solutions for Life Sciences

UNDERSTAND FDA REGULATORY OBSERVATION TRENDS.

Insider Intelligence
PROFESSIONAL SERVICES

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

ComplyFDA can be trusted to help companies achieve and maintain compliance, as it offers a comprehensive suite of compliance services, including FDA inspection preparation, quality system audits, and regulatory document preparation. ComplyFDA’s team of experts have extensive experience in the pharmaceutical, medical device, and biologics industries, and are knowledgeable in current Good Manufacturing Practices (cGMP), Quality System Regulation (QSR), and other regulatory requirements. By partnering with ComplyFDA, companies can benefit from their expertise in navigating the complex FDA regulatory landscape, reducing the risk of non-compliance, and ultimately avoiding costly and reputation-damaging warning letters and 483s.

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.

DON’T TAKE CHANCES, SCHEDULE A VIRTUAL CONSULTATION NOW

Stay Ahead Of The FDA. Schedule Now.

REQUEST CONSULTATION

Only takes a few seconds!