Services

Allay is the one-stop-shop for all of your THC Cannabis, Hemp and Psychedelic Compliance needs.

Highlighted Services

cGMP Gap Analysis

Interested in getting cGMP certified but unsure of where to start? Allay can provide a detailed roadmap of how to get there and help avoid compliance pitfalls along the way.

Floor Plan Review

Make sure your new build is up to compliance standards before you even break ground. A simple review often saves our clients thousands in additional costs.

Label Review

At Allay, we ensure that your labeling is compliant in order to help keep customers safe, keep your products on the shelf, and protect your company from fines and recalls.

SOP Development

We can help you build your SOPs so that you don’t have to. SOPs are a crucial step towards making sure your business operates in a way that complies with industry regulations.

Testimonials

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.”

all Services

OSHA Compliance

OSHA has jurisdiction among all cannabis companies in the US. OSHA exists to ensure safe and healthful working conditions for working people. The safety of your employees is important and Allay Consulting can assist you with workplace evaluation, required documentation, SOP’s, and employee training to ensure your workplace is OSHA compliant. OSHA will likely visit your company’s facility sometime in the near future, don’t risk unknowingly having an unsafe work environment and getting fined by not being compliant.

FDA Compliance

Product safety standards cover everything from employee hygiene, food handling, safe sourcing of ingredients, traceability, to temperature control requirements, etc. While some states and counties have scheduled local health department inspections, others are still working towards developing their requirements. Upgrading to compliant product safety standards now can reduce the risk of outbreaks, hefty fines, closures, or even loss of license.

Allay can assist with CFR 117(food/food ingredients), 111 (dietary supplements) & 211 (pharmaceutical) regulations. The easiest way to become FDA compliant is through cGMP certification.

CGMP Certification Assistance

cGMP stands for Current Good Manufacturing Practices and is promulgated by the FDA. cGMP regulations require a quality and safety approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. It is designed to reduce the risks involved in all steps of the manufacturing process.

Allay Consulting are cGMP/ FDA experts and can help your company evaluate the workplace, put together all of the required documentation, SOP’s, ensure quality assurance, and training required to receive the certification from an accredited certifying body. The best way to understand where your business stands with compliance is to schedule a full cGMP gap analysis with an Allay Consultant.

GACP Certification Assistance

A popular certification for cultivators is the Good Agricultural and Collection Practices (known as GACP or GAP). This highly sought after certification is the equivalent of cGMP certification but specific to cultivations. The GACP is a robust audit process that demonstrates cultivators are growing their plants safely, growing with quality and with consistent best practices. Agricultural practices help ensure the wellbeing of their consumers, workers, and to protect the environment in which they’re working.

Organic Certification Assistance

Allay assists hemp cultivation facilities and hemp product manufacturers achieve USDA organic certification by developing and implementing the SOPs needed to ensure organic integrity from farm to consumer. Allay can interface with the organic certifying body and put together the application packet, as well as conduct an onsite gap analysis to prepare the business for the certification audit.

Although USDA organic certification is not currently available to the THC cannabis industry, similar program certifications are available that Allay can assist THC cannabis businesses with.

ISO 9001 Certification Assistance

ISO 9001 is a quality management compliance certification that is geared toward a variety of plant-based medicine companies. This certification helps ensure companies implement a quality management system (QMS) to ensure customer satisfaction and continual improvement. Allay Consultants can assist with implementing the ISO standard through documentation, trainings, and including quality management in the culture of the company.

State Regulations

Every state has different and unique regulations and rules that companies have to follow in order to stay compliant and operational. Unfortunately, these regulations are constantly evolving as the hemp and THC cannabis industry matures. Everything from SOPs, to inventory management, to floorplan requirements, to product management, and security can all differ from state to state.

The good news is that Allay Consulting can help your company stay compliant no matter if you are in one state, or a multi-state operator (MSO).

Gap Analysis (Mock Audits)

Thinking about buying a cannabis company or investing in one but don’t know enough about compliance to know if it’s a great idea? Already have the facility that needs a regulatory review? Allay Consulting frequently conducts facility audits to ensure state specific compliance, cGMP, GACP, OSHA, ISO, and organic compliance. This is typically the first step when seeking to achieve various certifications. Start with a gap analysis to understand your company’s compliance pitfalls. Allay provides a detailed roadmap of each step your business must take before becoming compliant.

We can perform GAP analysis for the following compliance standards:

  • cGMP
  • GACP
  • OSHA
  • ISO
  • Organic

Floor Plan Review

The Floor Plan Review is a form of gap analysis that typically takes place before a facility is operational, and it is best practice to ensure they are built with applicable regulations and standards in mind. Making sure a company has good production flow, compliant surfaces, equipment, drainage, and ventilation are all things being considered during a plan review. This is an area where Allay saves our clients a lot of money by preventing costly facility updates down the line.

Label Review

When a consumer sees your product on the shelf, labeling is one of the first things that jumps out at them. Unfortunately, designing the correct labels for products can be difficult when so much of it is mandated by regulatory standards. Avoiding false statements and broad health claims can be difficult to try to navigate through as an emerging business.

At Allay, we ensure that your labeling is compliant in order to help keep customers safe, keep your products on the shelf, and protect your company from fines and recalls.

SOP Development

An SOP, is a set of step-by-step instructions to help workers carry out routine operations. With our unique approach, Allay can help your business build SOPs to achieve efficiency and performance, while reducing miscommunication and failure to comply with industry regulations.

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