Your Partner for  your GxP and Regulatory Compliance Needs

Our Expertise

Compliance and Regulatory Consulting Services

  

Sweetgrass GxP Group, LLC (“Sweetgrass GxP”), provides Quality consulting services to ensure our valued clients develop and provide high-quality, safe and effective products to their patients.  Our goal is to facilitate the design, implementation and maintenance of Quality systems that produce superior products on a consistent basis, while meeting the myriad of compliance requirements of the FDA and other global regulatory bodies.


Sweetgrass GxP’s philosophy is to always meet the needs of our clients by delivering Quality services on-time in a professional and practical manner.  We believe trust and integrity are integral in the Quality services industry, and the foundation of our client relationships.


Our Managing Partner, Paul Eichholz, MSJ, has 20 years of real-world experience tackling complex GxP-related challenges and issues.  As a small firm, Sweetgrass GxP  offers uniquely personalized services tailored to your organization’s specific needs.  Compliance and other challenges in the highly regulated industries of Pharmaceuticals and Compounding Pharmacies are highly complex; let Sweetgrass GxP be your partner in overcoming those challenges.  Sweetgrass GxP Group, LLC  is a 100% Veteran-owned business.  


Pharmaceutical and Medical Device Services

   

Proactive Compliance Solutions and Services


  • Quality Systems Development, including Electronic Quality Management Systems
  • Supplier Audits
  • Current Good Manufacturing Practices (cGMP) Training
  • Standard Operating Procedure (SOP) Development and Training
  • Corrective and Preventive Action Development
  • Risk Assessments
  • Mock FDA or Other Regulatory Body Inspections
  • Temporary Quality Assurance or Regulatory Affairs Support
  • Equipment Qualification
  • Process / Cleaning Validation
  • Laboratory Qualification


Mitigation and Remediation Services

  • FDA Form 483 Response Development, Review and Support
  • FDA Warning Letter Remediation Plan Design, Development, Execution, and Support
  • Consent Decree Remediation Plan Execution and Support
  • Product Recall Management and Support
  • DEA Remediation Plan Development, Execution, and Support


   

Pharmacy Solutions and Services

Compliance Solutions for 503A and 503B Compounding Pharmacies


  • USP Compliance
  • USP 795 Gap Assessments, Policy and Procedure Development, Staff Training
  •  USP 797 Gap Assessments, Policy and Procedure Development, Staff Training to Support December 2019 Implementation
  •  USP 800 Gap Assessments, Policy and Procedure Development, Staff Training and Proactive Facility Design and Support to ensure compliance by December 2019 Implementation
  • State Board of Pharmacy Inspection Readiness and Gap Assessments 
  • Remediation for State BOP and FDA Enforcement Actions 
  • DEA Compliance Gap Assessments and Remediation Support 


503B Outsourcing Compliance Support


  • FDA Form 483 Response Development, Review, and Support
  • FDA Warning Letter Remediation Plan Design, Development, Execution, and Support
  • Product Recall Management and Support

 





Sweetgrass Blog

Testimonials

Working with Sweetgrass GxP was, and continues to be an extremely valuable experience.  The firm's knowledge is deep and diverse, and they posses a unique ability to take highly complex regulatory and quality requirements and break them down into understandable findings and easy to implement deliverables. I look forward to continue working with Sweetgrass as we grow and develop as a business. 


David Presper

President

Direct Scripts, LLC

   

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How can we partner with you today?

SweetgrassGxP Group, LLC

1408 N Westhsore Blvd Suite 704, Tampa, Florida 33607, US

(636) 209-1929