Psilocybin

Psilocybin is a psychedelic compound found in some forms of mushrooms. The use of psilocybin has recently been approved in some areas of the United States. Allay Consulting supports businesses interested in cultivation, manufacturing, and providing safe and compliant products for psilocybin consumers. We assist with regulatory compliance and safety for all compliance for all psilocybin license types!

Services

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. Contact us to get a quote!

FDA Compliance Assistance

As Food Safety Experts we can apply existing food safety standards to psilocybin products to promote the production of a safe product free from potential contaminates. This would cover everything from employee hygiene, food handling, temperature control requirements, etc. Upgrading to good food safety standards now can reduce the risk of outbreaks, hefty fines, or even closure.

Licensing

Obtaining and maintaining your psilocybin company licensing can be a long and difficult process. Allay Consulting consultants can asset with filling out, organizing and submitting paperwork to gain licensing or to maintain licensing.

Compliance Logs

Creating a record of your various processes, be it sanitation, training, critical control points, calibration, etc., can help you easily maintain compliance at your facility. Documenting compliance activities with logs protects the company from potential disposals, outbreaks, and recalls.

cGMP Support for Certification

cGMP stands for Current Good Manufacturing Practices and is promulgated by FDA. cGMP regulations require a quality management 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 create and implement all of the required documentation, SOPs 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 9001 for Certification

ISO 9001 is a quality management compliance certification that is geared toward a variety of companies, including psilocybin. This certification helps ensures companies implement a quality management system to ensure a 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.

Due Diligence Audits

Thinking about buying a psilocybin company or investing 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.

Good Agricultural Practices (GAP)

Good Agricultural Practices and Good Handling Practices to ensure psilocybin is produced, packed, handled, and stored as safely as possible. The goal is to identify and correct hazards that could result in microbial contamination. Allay consultants can assist with becoming compliant to GAP standards to prepare companies for GAP certification.

HACCP Certification/Food Safety Plans

HACCP (Hazard Analysis Critical Control Point) and a Food Safety plan are systematic preventive approach to food safety that analyze biological, chemical, physical and radiological hazards in production processes that can cause the finished product to be unsafe. These plans are a proactive approach to reduce health and safety risks through preventative controls.

Standard Operating Procedure (SOP) Development

An SOP is a set of step-by-step instructions to help workers carry out routine operations. With our unique approach to psilocybin compliance consulting, we build SOPs, Documentation, Plans, and logs to achieve efficiency and performance, while reducing miscommunication and failure to comply with psilocybin industry regulations and standards.

OSHA Compliance

OSHA has jurisdiction of all companies in the US, including psilocybin facilities. OSHA exists to ensure safe and healthful working conditions for employees. The safety of your personnel is your legal responsibility, and Allay Consulting is well equipped to assist with creating required documentation, provide unique facility SOPs, conduct equipment/facility evaluations, review personal protective equipment (PPE) evaluations, and provide employee trainings. Don’t risk getting fined by not being compliant.

Facility Build Outs & Facility Updates

Starting a new facility requires expertise in both functionality (plan review) and in regulations (health, building dept). Any missteps or oversights could mean starting over from square one. Allay Consulting reviews facility build out to ensure health & sanitation requirements, and worker safety needs.

ISO 22000 for Certification

ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain. Becoming ISO 22000 certified reveals the company has integrated a food safety management system. This certification is more in depth and complicated compared to cGMP standards but provides additional customer confidence in your product. Allay Consulting aligns your food safety management system to the required written documents, SOPs and training. Want to know where your company stands? Schedule a full ISO 22000 Audit today to find out.

Compliance Training

Training is required in most regulations that your company will need to be compliant with. Our consultants can develop individualized trainings that you can conduct in house or our Compliance Experts can conduct onsite or mobile training on FDA, cGMP, OSHA, emerging issues, points of emphasis, regulation changes, and ways to improve facility compliance. We are flexible to the needs of your company and will structure all trainings to your specific company needs.

SUPERIOR QUALIFICATIONS

Former regulators. Countless Certifications. With Allay, you get the industry’s best and brightest.

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