Digamma Consulting's Services
Compliance
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QAQC program design
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Legally defensible data
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Method Development
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Method Validation
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Staff Training
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ISO 17025 and State License
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OSHA and Occupational Hazards
Facilities
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Lab Design and layout
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Instrument Purchasing Choices
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Standards, Consumables, Equipment
Permits and licenses
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State license application
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Local permit application
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Laboratory certification: ISO 17025
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DEA License (Federal Hemp)
Analysis
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Potency Analyses
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Cannabinoids
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Terpenes
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Contaminant Analyses
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Pesticides / Mycotoxins
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Residual Solvents
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Heavy Metals
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Microbiology
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Other Tests
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Moisture and Water Activity
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Environmental Tests
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Contaminants
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Environmental monitoring for microbial pests, toxic heavy metals, and pesticide exposure
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Pest control, management and prevention strategies
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Pesticide, microbial, and heavy metal compliance
Optimization
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Chemical analysis Method Development, Validation, and Certification
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Laboratory cost-benefit optimization
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Staff Training and Assessments
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Analytical Throughput Optimization
Compliance
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QAQC program design
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Food Safety Compliance
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Compliant and safe products for extraction and production
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OSHA and Occupational Hazards
Facilities
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Research laboratory
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Extraction laboratory
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Formulation Laboratory
Permits and licenses
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State license application
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Local permit application
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Food safety certification
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Laboratory certification: ISO and GMP
Analysis
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In-House Cannabinoid Analysis
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Validation with Legally Defensible Data
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In-House Contamination Analysis
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Third-Party Lab Audits
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Investigations into Generation of False Laboratory Data
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Contaminants
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Environmental monitoring for microbial pests, toxic heavy metals, and pesticide exposure
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Pest control, management and prevention strategies
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Pesticide, microbial, and heavy metal compliance
Optimization
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Design of experiments and research projects
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Chemical extraction method development
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Pharmaceutical compounding and dosing
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Harvest optimization
We have seen a widespread problem in the industry, cannabinoid (particularly THC) inflation by labs in nearly each of the 16 states we have worked in. We know that regulators are eager to curb this phenomenon but are unsure of what effective actions by regulators would end this practice. We believe we have solutions which we have outlined here.
Solution A: Data Analytics
We recommend a data analysis report similar to what is produced by the Emerald PT Report (see: Emerald Test) or what has been created by some labs lobbying state governments to take action on cannabinoid inflation. Data such as this would be relatively inexpensive to generate and will provide a firm basis for regulatory and government action, whether for enforcement or other constructive purposes.
Solution B: Suspect Product Check Program (Secret Shopper Program)
We propose the adoption of an affordable “Suspect Product Checks (Secret Shopper)” plan whereby any state can run a very low-cost laboratory analysis to periodically and randomly sample the products of licensed distributors and test them for inflated cannabinoid values. What this allows is an impartial and equal basis for enforcement of suspected inaccurate lab data, in a way that does not allow labs to intentionally manipulate data to evade detection in ways that apply to Round Robbin and Proficiency Testing style programs. The critical variable in any regulatory or legal challenge is creating and maintaining defensible chemical analysis data to use as a basis for enforcement and to defend against outside parties. This often involves a state reference lab that can validate its analytical methods to legally defensible status and use that data as a basis for enforcement in a Suspect Product Check Program like the one outlined above. Digamma can help define, regulate, and define the validation criteria for the state regulatory enforcement agencies and assist in the build-out and validation of laboratory methods that meet these definitions.
Solution C: Laboratory Audits
Audits by chemical analysis experts are needed to regulate the issues in cannabinoid inflation, whether performed by state auditors or 3rd party organizations contracted by the government. Such audits would give the state information to know if the data inaccuracy was intentional, or if other government regulatory action is appropriate. What Digamma has been developing with its over 10 years of experience is a knowledge of how cannabis methods are performed, measured, and legally defended to be accurate according to industry standards practiced in EPA / FDA-regulated laboratories. This has allowed us to generate a comprehensive cannabis laboratory audit program that allows us to investigate and determine the cause of any data anomalies or inaccuracies with certainty. This program can be used as a basis to define and outline regulations or administrative codes, train state staff, or out-source auditing services to a qualified 3rd party that can perform this vital service for the state.
White Paper on Cannabinoid Inflation Solutions
Read the full paper on Digamma's Solutions for Cannabinoid Inflation
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Cannabis Laboratory Licensing Expertise
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Expert scientific witnesses
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Expert opinion letters
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Merger, and acquisition services
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Chemical science consultations for certificates of analysis and audits of labs that produce them
Digamma Consulting Provides Unparalleled Cannabis Chemistry Legal Support: Tailored Solutions for Lawyers
Cannabis Laboratory Compliance
Digamma Consulting provides expert strategic guidance and pre- and post-licensing assistance. Our team stays abreast of evolving regulations, helping our clients to ensure compliance and minimize legal risks in every aspect of cannabis operations. With our extensive experience building up so much of the analytical sector of the cannabis industry across so many jurisdictions, there is no team better out there to assist you with cannabis laboratory compliance and operations.
Cannabis Litigation
Digamma Consulting offers comprehensive support for civil and criminal cases, from product liability claims to disputes over THC inflation, as well as providing scientific opinion letters to achieve favorable legal outcomes. 1. Liability claims. 2. Laboratory Fraud and Inaccuracy (THC inflation) disputes. 3. Providing scientific evidence to support legal strategies. 4. Providing opinion letters (ex: scientific data to discredit CoAs from errant labs). Digamma Consulting offers comprehensive support for civil and criminal cases, from product liability claims to disputes over THC inflation, as well as providing scientific opinion letters to achieve favorable legal outcomes. 1. Liability claims. 2. Laboratory Fraud and Inaccuracy (THC inflation) disputes. 3. Providing scientific evidence to support legal strategies. 4. Providing opinion letters (ex: scientific data to discredit CoAs from errant labs). In particular, the issue of Certificate of Analysis (CoA) produced by cannabis testing laboratories with demonstrably false information is proliferating in the industry. Many of the CoAs that are the basis for legal disputes and enforcement action, sometimes costing producers large sums of money, often rely on inaccurate data that can be either discredited or dismissed with the right laboratory auditor and data investigator, skilled in laboratory analytical processes and regulation.
Expert Witness Support
Digamma Consulting offers expert witness services, leveraging our team's extensive knowledge of chemical sciences and our experience in cannabis laboratory science practices for over 12 years. We help create compelling testimony and strengthen legal arguments involving testing labs, manufacturers, and producers. Our services have been used to demonstrate inaccurate testing for manufacturers, awarding them many thousands of dollars in refunds for inaccurate and legally indefensible testing. We have provided support against criminal prosecution for cannabis operators being investigated by local, state, and federal authorities, providing testimony that allows for prosecutor claims to be negated, such as threats to public safety, human health, and other concerns of that nature.
Cannabis Science Expertise
Digamma Consulting provides expert analysis and interpretation of laboratory certificates of analysis for lawyers and clients. Our team specializes in assessing data reliability, legal defensibility, and the analytical process, offering insights into product formulations and environmental chemistry. Our expertise can identify sources of contamination and verify testing accuracy, crucial in legal cases with significant financial implications. 1. Data accuracy & reliability 2. Legal defensibility of lab data 3. Analytical processes 4. Sources of contamination The sources of contamination have become a very large issue in the industry, particularly with the more prevalent mold analysis causing batches of cannabis products to be failed. At Digamma we have witnessed dozens of times when this happens. Many operators and regulators are unsure of who to blame, but with our methodology, based on EPA guidelines, we have been helping the cannabis industry identify, measure, locate, and prove sources of contamination beyond doubt.
Expertise in Cannabis Chemistry and Analysis Laws and Regulations
At Digamma Consulting, we understand the unique needs of cannabis stakeholders and their legal representatives. From overcoming regulatory hurdles to addressing THC inflation concerns, we deliver tailored solutions to support legal strategies and drive success in the cannabis industry. At Digamma we have been working with cannabis testing labs for over 10 years, and are familiar with the legal pathwork of well-meaning but - under resourced state regulators. We have successfully helped laboratories win awards to test cannabis across 16 US states and are prepared to communicate, comply, and when necessary negotiate with state regulators in a wide variety of contexts, particularly in laboratory science and public safety and supply chain testing.