FDA Compliance, cGMP Compliance, OSHA Compliance, and Licensing
We offer a broad range consultative services to help your organization understand and navigate the growing number of rules and regulations that apply to the cannabis and psilocybin industries. Our team of experts are available to engage through baseline assessments, customizable packages, or hourly professional services agreements.
How We Work
One-time Compliance Audits
Don’t know where to start? Aren’t sure how compliant your already existing facility is? Allay Consulting can help! You choose what standards you want to be audited to and we can send a compliance expert to the facility to consult a one-time audit. This will give you lots of information and give you a base line of what your company might, or might not need improving on. Pricing varies depending on standard (State Regulations, FDA, OSHA, cGMP, ISO 9001, ISO 22000) and travel cost.
Customizable Retainer Packages
After conducting a Baseline Assessment of a facility, our consultants will work with your company to build a package that fits your needs. While our packages always include a monthly number of hours that can be used for an onsite audit and followed up by a comprehensive compliance report, any number of compliance projects can be completed using those set monthly hours. Your Allay Consultant can help itemize and prioritize exactly what your company needs.
Hourly Professional Services
If your company is unsure of scope, or simply has a project or two that need attention, Allay can easily create an hourly plan. Ultimately, it is our job to make sure the product you create ends up in stores, not disposed of. While our hourly rate is usually the more expensive option, it can be beneficial in light of unforeseen or urgent situations, to ensure nothing falls through the cracks.
Product Safety Evaluation
Eventually, the FDA will require every product on the market to be evaluated and approved. The Product Safety Evaluation is an easy way to organize each product made in your facility, so they are easily available to regulators. In some states such as Colorado these evaluations are required to sell certain products that are high risk products (Audited Product Evaluations). Allay Consulting has Certified Quality Auditors on staff that are approved to conduct these kinds of product evaluations. Avoid costly shutdowns by gathering and preparing all the relevant product information, before they ask.
Standard Operating Procedure (SOP) Development
Allay Consulting can assist with all required documentation and SOP’s for; FDA, cGMP compliance, ISO 22000 Compliance, and OSHA. Please contact us for pricing, timelines, and retainer packages.
cGMP stands for Current Good Manufacturing Practices and is promulgated by FDA. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups, and errors. It is designed to minimize the risks involved in all steps of the manufacturing process. Allay Consulting are cGMP/ FDA experts and can help your company put together all of the required documentation, SOP’s and trainings required to receive the certification from an accredited certifying body. Want to know where your company stands? Schedule a full cGMP Audit today to find out.
ISO 22000 Compliance
ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This is more in depth and complicated than cGMP standards but provides more customer confidence in the product. Allay Consulting can help your company put together all of the required documentation, SOP’s and trainings required to receive the certification from an accredited certifying body. Want to know where your company stands? Schedule a full ISO 22000 Audit today to find out.
ISO 9001 for Certification
Comprehensive Compliance Report
The Compliance Evaluation, also known as a GAP assessment, is a written report delivered after the completion of the Baseline Assessment outlining violations in your facility. This report will explain each violation, reference regulations, and provide corrective actions.
Compliance Consultants On-Demand
If you have a question, feel free to call and ask about our Cannabis Consulting Services. As the industry continues to grow and evolve, no regulations are set in stone. Laws that exist today, may not exist tomorrow… and we may find six more in its place! By hiring Cannabis Consultants or Compliance Consultants On-Demand, you get a resource to track these changes for you, explain each one relevant to you in a way that makes it easy to understand and ultimately, outline steps you need to take, to comply.
Due Diligence 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? Allay consulting can conduct an onsite audit of any facility that you already invest in, are thinking about investing in, or thinking about buying. Protect your investment by being in the know from the beginning.
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 audit to prepare the business for the certification audit. Although USDA organic certification is not currently available to the marijuana industry, similar program certifications are available that Allay can assist marijuana businesses with.
OSHA now has jurisdiction among all cannabis companies in the US. OSHA exists to ensure safe and healthful working conditions for working men and women. The safety of your employees is important and Allay Consulting can assist you with the required documentation, SOP’s and employee trainings required to be OSHA Complaint. OSHA will most definitely visit your company’s facility sometime in the near future, don’t risk getting fined by not being compliant.
Cannabis Authenticity and Purity Standard (CAPS) Certification
The Cannabis Authenticity and Purity Standard (CAPS) sets the global gold standard in product safety, quality, and authentication for cannabis production, distribution, and sale. It sets out the requirements for good manufacturing practice (GMP) and good agricultural practice (GAP), which are supplemented with detailed scientific standard operating procedures to establish product identity, authenticity, and consistency. The standard is underpinned by science and is outcome-based. It allows for flexibility in approach and is not unnecessarily prescriptive, helping organizations achieve their regulatory and risk-based objectives.
Contact Us Today!
Learn how cannabis consulting can help move your business forward.