Build FDA & GMP Compliant Operations

Building a Regulatory-Ready Cannabis Business with RQMIS

Success in the Cannabis industry demands more than just passion—it requires a deep understanding of the regulatory landscape, a structured operational foundation, and a commitment to quality, safety, and scalability. At RQMIS, we provide the expertise and tools to help you navigate these complexities while building a resilient and compliant business model.

Key Elements for Long-Term Success in the Cannabis Industry

1. Comprehensive Regulatory Perspective:
   • Gain a clear understanding of local, state, and federal regulations governing Cannabis cultivation, processing, distribution, and sales.
   • Stay informed about regulatory changes to ensure continuous compliance and adaptability.
   • Develop a regulatory roadmap to streamline licensing, quality management, and product approvals.
2. Structured Business Operations & SOPs:
   • Develop and implement Standard Operating Procedures (SOPs) that align with Good Manufacturing Practices (GMP) and Good Agricultural and Collection Practices (GACP).
   • Create scalable systems to support operational growth without compromising compliance or quality standards.
   • Document every step of your processes to ensure audit readiness and regulatory transparency.
3. Adopt Good Practices (GxP):
   • Implement industry-standard Good Practices (e.g., GMP, GACP, GDP) to ensure consistent product quality, safety, and efficacy.
   • Integrate risk management strategies to proactively address potential challenges in manufacturing and distribution.
4. Build a Strong Compliance Team:
   • Assemble a dedicated compliance team trained to monitor regulatory adherence, handle inspections, and oversee quality assurance processes.
   • Ensure ongoing training and education for your team to stay updated with evolving regulations and best practices.
5. Prioritize Safety, Efficacy, and Scalability:
   • Develop systems that prioritize employee safety throughout cultivation, manufacturing, and distribution processes.
   • Validate product efficacy through rigorous testing and data-driven methodologies.
   • Design scalable operational models to support business growth without regulatory bottlenecks.

How RQMIS Supports Your Quality Management System (QMS) for FDA Medicinal Cannabis Compliance

At RQMIS, we specialize in developing and implementing robust Quality Management Systems (QMS) tailored to meet the FDA’s regulatory requirements for medicinal Cannabis products.

Our QMS Services Include:

• Development and integration of a customized QMS aligned with FDA regulations and ISO 13485 standards.
• Documentation and implementation of Standard Operating Procedures (SOPs) for key processes.
• Assistance in developing clear and accurate marketing claims backed by empirical data to ensure compliance with FDA labeling and marketing guidelines.
• Support in product risk assessments, CAPA processes, and complaint management systems.
• Continuous monitoring and improvement of QMS performance.

Inspection Readiness with RQMIS: From Preparation to Success

Preparing for regulatory inspections can be a daunting task, but with RQMIS by your side, you can approach it with confidence and clarity.

Our Inspection Preparation Services Include:

• Comprehensive pre-inspection assessments to identify and address potential compliance gaps.
• Assistance in developing inspection-ready documentation and technical files.
• Conducting mock inspections to simulate real-world regulatory audits.
• Training staff to handle inspector questions and demonstrate compliance protocols.
• Post-inspection support, including corrective action plans and addressing findings promptly.

With RQMIS, achieving a satisfactory inspection result is not just a goal—it’s an expectation.

Why Choose RQMIS as Your Strategic Compliance Partner?

• Industry Expertise Across Regulated Sectors: Proven experience in medical devices, pharmaceuticals, dietary supplements, and medicinal Cannabis.
• Customized Solutions: Tailored strategies that align with your unique business goals and regulatory requirements.
• Proactive Compliance Management: Systems designed to prevent issues before they arise.
• End-to-End Support: From regulatory strategy development to post-market surveillance, we’re with you every step of the way.

Let RQMIS Guide You to Regulatory Excellence

By partnering with RQMIS, you’ll gain access to a team of experts dedicated to building compliant, scalable, and future-ready operations for your Cannabis business.

• Ensure regulatory compliance with confidence
• Achieve inspection readiness and success
• Establish a robust Quality Management System (QMS)
• Secure sustainable growth through structured operations

Let’s build a foundation for your long-term success together.