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

Brandon Metoyer, Chief Operating Officer, Contract Canna

Allay expedited our cGMP certification for our cannabis manufacturing facility. Their expertise in Good Manufacturing Practices, Document Management Systems, and Facility Standards, gave us all of the foundational components for our business to execute the GMP Inspection, and consequently, receive our cGMP Certification. The process was convenient due to the monthly cadence of cGMP standard rollouts, which made their services very convenient for a start-up manufacturing company.

Gregson Feeley, Compliance Manager at Medically Correct LLC

“We are incredibly grateful to Allay Consulting for their professional and reliable cannabis compliance consulting services. They showed great care and respect for our health and well-being during the pandemic by following all the necessary protocols and precautions while being knowledgeable, professional, and friendly. Kelsey and Sheila provided valuable guidance and support throughout the entire process, from design to implementation, advising us on navigating the complex processes involved with creating audited products in the Colorado Marijuana Industry. They helped us design and implement Standard Operating Procedures that meet the state regulatory requirements while also helping to enhance the consistency of our audited product, ensuring the highest standards of quality and safety. Thanks to Allay, we can produce and deliver a safe, effective, and compliant product to our patients in need. We are delighted with their services and highly recommend them to anyone needing cannabis compliance consulting for audited products, GMP, or anything else!”

Andy Kester, CSO at Elevated Softgels - CBD Manufacturer

“Allay Consulting was an invaluable resource for our company as we pursued various aspects of regulatory compliance. Allay’s staff was extremely professional, personable, and knowledgeable on a broad range of topics affecting our operations. From post-visit reports to random compliance questions, Allay has always been timely, responsive and practically helpful; their customer service and commitment to quality is second to none.”  

Mill Lane Chemists

“Allay Consulting was instrumental in getting our pharmacy business cGMP certified in New York. Kara Lavaux and Kimberly Stuck were a valued partner before, during and after our certification. Their knowledge and attention to detail ensured that our facility was compliant and followed all state/federal laws, rules and regulations. They took an extremely daunting task and made it understandable, manageable and attainable!”

Shannon Kaygi, CEO at Eossi Beauty - CBD Topical Beauty Brand

“Kim and her team are great! I’ve worked with them in multiple capacities at multiple different companies and they never fail to deliver. I would highly recommend Allay consulting. I will never hire anyone else.

Tyler Clark, Vice President Operations at Clear Inc

“Allay Consulting has been key partners in helping our business effectively enter new markets and avoid costly foot faults. The team has helped us navigate each state’s set of unique sets of rules. A very valuable resource for all our compliance needs!”

Halston Trabucco of Clark Hill Law

“Kim is one brilliant entrepreneur! She is a well-connected professional that always takes the time to support anyone in her network. She has a very impressive background and profile, I recommend Kim Stuck as an expert to connect with on how to operate a compliant cannabis business!”

Chris Reno of Perry Johnson Registrars

“It’s rare that you come across a standout talent like Allay Consulting. The knowledge alone is impressive but the tools at Allay make it much easier for me to confidently refer clients to them, as I know they are in great hands. I’ve worked closely with their team helping Cannabis clients obtain Certifications across many cGMP, ISO & Food Safety standards. I’ve been witness to multiple round tables and speaking events of Kim’s and she easily commands the room. Top notch talent and a pleasure to call Allay an ALLY in the safety of the Cannabis Industry.”

Justin Schultz, Founder of Bison Botanics

“Working with Allay Consulting has been one of the best decisions we have made for our business. From building out our complete cGMP system to being present on audit day, our consultant makes us feel confident and comfortable with what can be a scary process. We will be clients forever!”

Jillian Townsend, Sr. Director

“If you are looking for a business that will help your cannabis company attain cGMP/HACCP/Dietary Supplement certifications, look no further than Allay Consulting. Working with Kelsey was an absolute pleasure and my mind was eased before the audit. Kelsey had every answer I needed and most importantly, she was trustworthy, professional, educated and responsive at any time during the day. In addition, Kelsey was there for the entire audit and made sure everything was in order and organized for the duration of the audit. The expertise from everyone I encountered at Allay Consulting was first class.”

Ed Chaney, CEO/Founder of Cannafyl

“As a manufacturer of the Cannafyl CBD brand, I engaged the Allay team to assist us with compliance requirements on the federal level.  I was impressed by their level of talent and participation, which at times exceeded the invoiced amount.  I was particularly impressed by how they stayed engaged until the matter was fully resolved.  The final outcome was intelligent, thorough and easily integrated into our operating protocol.”

Skip Mogill, Compliance Officer at ECS Brands

“We were on a fast track to become a cGMP certified manufacturing facility, so we contracted Allay consulting in February of 2020 to help us out. We were building out our facility and just starting to develop SOP’s. We were certified in September 2020. Since then, Allay has done an outstanding job supporting us in this everchanging regulatory climate. They have been a great business partner and I highly recommend Allay Consulting.”

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.

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