Orion GMP Solutions
Orion GMP Solutions is a pharmaceutical consulting firm established in 2015, based in Detroit, MI. It specializes in providing expertise in Pharmaceutical Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) to the international cannabis industry. The company aims to help clients meet regulatory requirements, optimize their operations, and produce high-quality, patient-first cannabis products. Orion GMP Solutions offers a range of services including GMP implementation, assessments and diagnostics, process engineering, quality management, and project management, with a focus on risk-based systems and international standards.
Industries
Nr. of Employees
small (1-50)
Orion GMP Solutions
Products
GACP Assessment
A guided remote GACP audit designed to assess a cannabis cultivation's operational readiness to access international markets and meet international guidelines.
Assessments & Diagnostic Analysis
Comprehensive diagnostic assessment of business operations to adhere to certifications and regulations that apply to the cannabis industry, including gap assessments, compliance audits, and detailed reporting.
Cannabis Quality Management Systems Consulting
Consulting services focused on implementing pharmaceutical-grade Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) tailored to the international cannabis industry.
cGMP Implementation Services
Comprehensive implementation services for Current Good Manufacturing Practices (cGMP) in the cannabis industry, designed to achieve operational control and exportation possibilities to the European Union.
Quality Management Services
Quality management services including QMS design, documentation design and development, supporting documentation, and Quality Assurance support.
Project Management Office Services
Proactive project management services designed to guide cannabis compliance and facility projects to success while anticipating obstacles.
GACP Assessment
A guided remote GACP audit designed to assess a cannabis cultivation's operational readiness to access international markets and meet international guidelines.
Assessments & Diagnostic Analysis
Comprehensive diagnostic assessment of business operations to adhere to certifications and regulations that apply to the cannabis industry, including gap assessments, compliance audits, and detailed reporting.
Cannabis Quality Management Systems Consulting
Consulting services focused on implementing pharmaceutical-grade Quality Management Systems (QMS) and Good Manufacturing Practices (GMP) tailored to the international cannabis industry.
cGMP Implementation Services
Comprehensive implementation services for Current Good Manufacturing Practices (cGMP) in the cannabis industry, designed to achieve operational control and exportation possibilities to the European Union.
Quality Management Services
Quality management services including QMS design, documentation design and development, supporting documentation, and Quality Assurance support.
Project Management Office Services
Proactive project management services designed to guide cannabis compliance and facility projects to success while anticipating obstacles.
Services
Implementation of current Good Manufacturing Practice systems for cultivation, extraction and pharmaceutical operations, including gap analysis and project plans to achieve GMP compliance.
Comprehensive diagnostic assessments and audits (3-5 day on-site or remote) to determine compliance readiness and produce detailed findings and remediation roadmaps.
Process development, validation support, and lean manufacturing implementations for cultivation and extraction workflows, including equipment selection and process optimization.
QMS design and documentation services including SOP creation, QA support, document control systems and training materials for regulated operations.
Project management services to coordinate GMP projects, prioritize tasks, identify obstacles and manage stakeholder communications to ensure timely delivery.
Training programs covering QMS, SOPs, problem solving, lean methodologies and GMP principles tailored to staff roles and organizational needs.
Implementation of current Good Manufacturing Practice systems for cultivation, extraction and pharmaceutical operations, including gap analysis and project plans to achieve GMP compliance.
Comprehensive diagnostic assessments and audits (3-5 day on-site or remote) to determine compliance readiness and produce detailed findings and remediation roadmaps.
Process development, validation support, and lean manufacturing implementations for cultivation and extraction workflows, including equipment selection and process optimization.
QMS design and documentation services including SOP creation, QA support, document control systems and training materials for regulated operations.
Project management services to coordinate GMP projects, prioritize tasks, identify obstacles and manage stakeholder communications to ensure timely delivery.
Training programs covering QMS, SOPs, problem solving, lean methodologies and GMP principles tailored to staff roles and organizational needs.
Expertise Areas
- cGMP implementation and certification
- Quality Management Systems (QMS) design
- Process engineering and facility design
- Analytical method development and lab management
Key Technologies
- Liquid chromatography–tandem mass spectrometry (LC-MS/MS)
- Inductively coupled plasma mass spectrometry (ICP-MS)
- High-performance liquid chromatography (HPLC)
- Gas chromatography (GC)
News & Updates
Discussion on challenges of analyzing pesticide contamination in cannabis for compliance and safety.
Showcasing innovative work in cannabis science at a major scientific conference.
Consulting services for a cannabis producer developing a product quality plan for a new license.
Support for a CBD oil manufacturer in meeting EU-GMP standards for export.
Study on airflow control and contamination prevention in GMP cannabis facilities.
Development of a rapid method for distinguishing cannabis cultivar varieties.
Discussion on challenges of analyzing pesticide contamination in cannabis for compliance and safety.
Showcasing innovative work in cannabis science at a major scientific conference.
Consulting services for a cannabis producer developing a product quality plan for a new license.
Support for a CBD oil manufacturer in meeting EU-GMP standards for export.
Study on airflow control and contamination prevention in GMP cannabis facilities.
Development of a rapid method for distinguishing cannabis cultivar varieties.