Services
Beyond equipment — Prodigy provides the engineering, training, consulting, and documentation services that turn a system purchase into a compliant, validated operation.
Lab Design-Build
Pharmaceutical-Grade Facility Design & Engineering
Prodigy's Lab Design-Build service delivers complete pharmaceutical-grade extraction and post-processing facility design, from initial concept through construction documentation and equipment installation. Our engineering team works with your facility team to design a layout that meets your throughput requirements, compliance obligations, and operational workflow.
Every Lab Design-Build engagement includes a full compliance gap analysis, equipment selection and specification, facility layout and utility design, and a documentation package suitable for state licensing, DEA registration, and GMP site authorization.
What's Included
- Compliance gap analysis and regulatory pathway assessment
- Facility layout and equipment placement design
- Utility design: HVAC, electrical, plumbing, and solvent management
- Equipment specification and procurement support
- C1D1 hazardous location design for hydrocarbon extraction areas
- GMP documentation: facility qualification, SOPs, and validation plans
- State licensing and DEA registration documentation support
- Construction documentation and contractor coordination
Operator Training
Certified GMP Extraction & Post-Processing Training
Prodigy's Operator Training program delivers hands-on, GMP-documented training for extraction and post-processing operators at all experience levels. Training programs are designed around your specific equipment configuration and compliance requirements, with documentation suitable for FDA and EU GMP training records.
Training is available on-site at your facility or at Prodigy's training facility, and can be customized to cover specific processes, equipment configurations, and regulatory requirements.
What's Included
- Equipment operation and safety training for ProX, MPS, and inTEST systems
- GMP documentation and batch record training
- Cleaning validation and CIP procedure training
- Process optimization and troubleshooting
- Deviation management and CAPA procedures
- Training documentation suitable for FDA and EU GMP records
- Competency assessment and certification
- Ongoing refresher training and support
API Consulting
Cannabinoid API Manufacturing Strategy & Regulatory Guidance
Prodigy's API Consulting service provides strategic guidance for operators entering the cannabinoid pharmaceutical API space. Our team of extraction engineers and regulatory specialists helps you navigate the complex intersection of cannabis regulation, pharmaceutical GMP requirements, and DEA Schedule III compliance.
Whether you're a cannabis operator upgrading to pharmaceutical compliance or a pharmaceutical manufacturer entering the cannabinoid API space, our consulting team provides the technical and regulatory expertise to accelerate your path to market.
What's Included
- Schedule III compliance strategy and DEA registration guidance
- Cannabinoid API manufacturing process development
- Regulatory pathway assessment: FDA, EU GMP, ICH Q7
- Process validation strategy and master validation plan
- Analytical method development and validation guidance
- Supplier qualification and vendor audit support
- CMC documentation for IND and NDA submissions
- International market regulatory strategy
GMP SOPs
Standard Operating Procedures for Pharmaceutical-Grade Operations
Prodigy's GMP SOP service delivers a complete library of standard operating procedures tailored to your equipment configuration, facility, and regulatory requirements. Every SOP is written to FDA 21 CFR and EU GMP EudraLex Volume 4 standards, with version control, review, and approval workflows built in.
SOP packages are available for individual processes or as a complete quality system documentation package, including equipment qualification protocols, cleaning validation procedures, batch records, and change control forms.
What's Included
- Equipment operation SOPs for ProX, MPS, and inTEST systems
- Cleaning and sanitization procedures with validation protocols
- Batch record templates and in-process control documentation
- Deviation, CAPA, and change control procedures
- Environmental monitoring and contamination control SOPs
- Training and competency assessment procedures
- Document control and records management procedures
- Quality management system (QMS) framework documentation
Validation & Commissioning
FAT, SAT, Commissioning, and Ongoing Qualification Support
Prodigy's Validation & Commissioning services cover the full equipment lifecycle from factory acceptance through ongoing performance qualification. Our engineering team executes structured testing protocols at every stage — ensuring your system meets specifications before it leaves the factory, upon installation at your site, and throughout its operational life.
Services are available as standalone engagements or bundled with equipment purchases. All documentation is written to support FDA and EU GMP inspection readiness.
What's Included
- Factory Acceptance Testing (FAT) — pre-shipment verification at fabrication facility
- Site Acceptance Testing (SAT) — post-installation verification at your facility
- Commissioning — system startup, utility verification, and operational readiness
- IQ/OQ/PQ execution support — hands-on qualification protocol execution
- Ongoing preventive maintenance programs — scheduled service and calibration
- Annual GMP audit support — re-qualification and compliance gap assessment
- Validation documentation packages for FDA and EU GMP submissions
- Remote monitoring and performance trending (where applicable)
Let's Build Your Compliance Infrastructure
Contact our team to discuss your service requirements and get a proposal tailored to your facility and regulatory pathway.
Contact Us