Markets
Comprised of former industry regulators, the Allay team has intimate knowledge and insight into the way the system works.
focused expertise
THC Cannabis
Every state that has legalized THC cannabis has their own unique requirements and challenges that can quickly become overwhelming to keep track of. We take care of the nitty gritty compliance work so that our clients can focus on running their business.
Hemp
The passing of the 2018 farm bill ushered in full legalization of hemp and hemp products. Unfortunately, federal regulations haven’t caught up yet, which creates a very challenging environment for hemp businesses across the country.
Psychedelics
Psychedelics are the next frontier of controlled substances that are being reevaluated for medicinal use. Unfortunately, in its youth the Psychedelics industry is still trying to figure itself out which leaves business scrambling for help.
Kratom
Allay Consulting works directly with the American Kratom Association to help businesses with all of their Kratom Compliance needs including: cGMP, OSHA, FDA, State Regulations, as well as reviews such as GAP analysis, and more!
Testimonials
Other Markets
Dietary Supplements – CFR 111 Compliance & Certification
Compliance with 21 CFR Part 111—the FDA’s Current Good Manufacturing Practice (cGMP) requirements for dietary supplements—is essential for ensuring product quality, safety, and regulatory readiness. Whether you’re preparing for growth, responding to evolving regulations, or seeking to build trust with retailers and consumers, CFR 111 certification through an accredited third-party certifier sets your operation apart.
At Allay Consulting, we provide full-service support to help you achieve and maintain CFR 111 compliance and certification—leveraging the same proven process outlined on our cGMP Certification page, with a focus on the unique needs of dietary supplement manufacturers, packagers, and distributors.
Food & Food Ingredients – CFR 117 Compliance & Certification
Compliance with 21 CFR Part 117—the FDA’s Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food—is essential for maintaining food safety, product quality, and regulatory compliance in today’s evolving marketplace.
Whether you’re manufacturing packaged foods, processing ingredients, or supplying raw materials, certification through an accredited third-party cGMP program strengthens your operations and demonstrates your commitment to safety and excellence.
At Allay Consulting, we offer full-service support to help you meet CFR 117 requirements and prepare for certification—following the same proven strategies outlined on our cGMP Certification page, tailored specifically for food and food ingredient manufacturers.
Pharmaceuticals – CFR 211 Compliance & Certification
The pharmaceutical industry operates under some of the most rigorous regulatory standards in the world. 21 CFR Part 211, the FDA’s Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals, sets the foundation for product safety, quality control, and regulatory compliance.
Whether you’re manufacturing, packaging, labeling, or distributing pharmaceutical products, achieving CFR 211 compliance—and third-party certification—demonstrates your commitment to product integrity and operational excellence.
At Allay Consulting, we provide comprehensive support to help pharmaceutical companies navigate CFR 211 requirements and prepare for third-party cGMP certification. Our process mirrors the services offered on our cGMP Certification page, tailored specifically for pharmaceutical operations.
Intoxicating Hemp Cannabinoids
As the hemp industry evolves, the legality of intoxicating cannabinoids—such as delta-8 THC, delta-10 THC, HHC, and others—continues to vary widely from state to state. While some states allow the manufacture and sale of these hemp-derived compounds, others have imposed strict limitations or outright bans.
At Allay Consulting, we help businesses understand the legal status of intoxicating cannabinoids in their specific jurisdiction and support compliance efforts in states where these products are permitted.
Kava – Regulatory Compliance & Certification
The kava industry is rapidly expanding in the U.S., but regulatory oversight remains inconsistent across federal, state, and local levels. As the marketplace grows, so does the need for standardized safety, quality, and manufacturing protocols that protect both consumers and businesses.
At Allay Consulting, we help kava manufacturers, processors, and distributors navigate the evolving regulatory landscape—and take proactive steps toward compliance and operational excellence through cGMP certification. By aligning your operation with recognized manufacturing standards, your business not only reduces risk but also plays a key role in legitimizing and professionalizing the kava industry as a whole.
Functional Mushrooms – Compliance & Certification
The functional mushroom industry is booming—but with rapid growth comes increased scrutiny. In response to recent product safety issues and outbreaks, the FDA is tightening its oversight, pushing many companies to take proactive steps toward regulatory compliance and quality assurance.
At Allay Consulting, we help mushroom product manufacturers, cultivators, and distributors navigate this shifting landscape by aligning operations with cGMP standards and, where applicable, mushroom-specific GACP protocols. Whether you’re producing capsules, tinctures, powders, beverages, or extracts, we provide the compliance foundation you need to scale safely and responsibly.
Adaptogenic & Herbal Supplements
As consumer demand for adaptogenic and herbal supplements continues to rise, so does the need for standardized quality systems and regulatory compliance. With growing FDA interest in product safety and labeling accuracy, more companies are proactively pursuing cGMP certification to legitimize their operations and stay ahead of potential regulatory changes.
At Allay Consulting, we help adaptogenic and herbal supplement companies navigate this evolving landscape—providing end-to-end support to meet 21 CFR Part 111 (dietary supplements) requirements and prepare for third-party cGMP certification.
Latest News & Information
Allay Consulting’s August Newsletter: Selling Dietary Supplements on Amazon
Selling Dietary Supplements on Amazon Amazon has become one of the largest sales channels for dietary supplements, but getting a supplement listed on Amazon is no longer simply a matter of having a compliant label and a Certificate of Analysis (COA). Amazon has...
Allay Consulting’s July Newsletter: GACP Certification for Cultivators – Building Quality from the Ground Up
GACP Certification for Cultivators - Building Quality from the Ground Up As the cannabis, hemp, medicinal plant, and botanical industries continue to mature, cultivators are facing increasing expectations from manufacturers, regulators, and consumers. It's no longer...
Allay Consulting’s June Newsletter: The FDA Is Watching, Is Your Facility Ready?
The FDA Is Watching, Is Your Facility Ready? For many food & dietary supplement manufacturers, the thought of an unannounced FDA inspection is enough to cause anxiety. And for good reason. An inspector can arrive without warning, request records, tour your...
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