Trusted Partner in GxP Compliance for Biopharmaceuticals

Welcome to Simply GxP Compliance LLC – your trusted partner in building robust GxP quality infrastructure for drug manufacturing and drug approvals. With 35+ years of industry expertise and a commitment to excellence, we help biopharmaceutical companies navigate regulatory requirements with confidence and full compliance.

About Us

Simply GxP Compliance LLC specializes in regulatory quality compliance in the areas of quality assurance, quality control, manufacturing, facilities, engineering, validation, drug development, nonclinical studies, different phases of clinical trials, and commercialization for the biopharmaceutical industry. Our mission is to support drug development and drug manufacturers in achieving USFDA and global regulatory compliance standards through expert guidance and streamlined processes.

Services

We offer comprehensive compliance solutions, including:

  • GxP Quality Infrastructure Development
  • Regulatory Compliance Consultation
  • Quality Assurance & Risk Management
  • USFDA & Global Regulatory Support
  • Training & Documentation
  • External & Supplier Quality Management
  • Phase Appropriate Quality Implementation

About Us

Simply GxP Compliance LLC specializes in regulatory quality compliance in the areas of quality assurance, quality control, manufacturing, facilities, engineering, validation, drug development, nonclinical 

 studies, different phases of clinical trials, and commercialization. quality assurance for the biopharmaceutical industry. Our mission is to support drug development manufacturers in achieving FDA and global US to FDA and regulatory compliance standards through expert guidance and streamlined processes.

Services

We offer comprehensive compliance solutions, including:

  • GxP Quality Infrastructure Development
  • Regulatory Compliance Consultation
  • Quality Assurance & Risk Management
  • FDA & Global Regulatory Support
  • Training & Documentation

About Us

Service Area

Our team provides expert consulting across key areas, including:

  • GMP (Good Manufacturing Practices) Compliance
  • GLP (Good Laboratory Practices) Guidance
  • GCP (Good Clinical Practices) Support
  • FDA Approval & Regulatory Strategy

Consultant Resources

Access valuable industry insights, whitepapers, and regulatory updates to stay informed and ahead in the competitive pharmaceutical landscape.

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