Ruvolo Enterprises

Your Partner in Quality Compliance

At Ruvolo Enterprises, we are dedicated to helping you achieve and maintain the highest standards of quality and compliance. Ruvolo Enterprises employs a diverse team of professionals with extensive expertise in Quality Management, Engineering, and Sales. Our multidisciplinary approach ensures comprehensive solutions tailored to meet the specific needs of your organization. Our team of experts is ready to partner with you to enhance your processes, ensure regulatory adherence, and drive continuous improvement.

Quality Management Systems

  • GAP Assessments: Identifying compliance gaps and areas for improvement to align with industry standards.

  • QMS Implementation: Designing and integrating a robust Quality Management System tailored to your operations.

  • Process Validation: Ensuring manufacturing processes produce consistent and high-quality results.

  • Equipment Qualifications (IQ/OQ/PQ): Comprehensive validation of your equipment to meet regulatory standards.

Our Services

Auditing Services

  • Internal Audits: Regularly assessing internal processes to ensure continuous compliance and improvement.

  • Supplier Audits: Evaluating suppliers to ensure they meet your quality and regulatory standards.

  • Mock FDA Audits: Simulating FDA audits to prepare your facility for actual regulatory inspections.

Regulatory Compliance

  • FDA, USDA, MoCRA, CSAR: Expertise in navigating complex regulatory landscapes to achieve compliance.

  • ISO Standards Implementation: Implementing and maintaining ISO standards such as ISO 9001, ISO 22716, and ISO 22000.

  • Clinical Labeling Requirements: Ensuring your clinical products meet stringent labeling regulations

Operational Strategies

  • Strategic Planning for Capacity Utilization: Maximizing your production capacity while maintaining quality standards.

  • Microbiological and Analytical Testing Oversight: Monitoring testing procedures to ensure accuracy and compliance.

  • Stability and Shelf-life Study Programs: Conducting studies to determine the stability and shelf-life of your products.

Documentation & Training

  • SOP Assessment and Writing: Developing clear and effective Standard Operating Procedures.

  • Training Programs: Creating and delivering customized training programs to enhance your team’s compliance knowledge.

  • Investigations/Root Cause Analysis: Conducting thorough investigations to identify and rectify root causes of quality issues.

Maryellen Ruvolo - Founder and CEO:

With over 30 years of experience in quality management and regulatory compliance, Maryellen Ruvolo is the visionary leader behind Ruvolo Enterprises. Her extensive background in pharmaceuticals, cosmetics, and food compliance has equipped her with the knowledge and skills to drive quality initiatives across various industries. Maryellen is dedicated to helping clients achieve operational excellence and regulatory success through innovative solutions and strategic planning.

Meet the Team

Lauren Vela - Lead Consultant:

Lauren Vela is a seasoned expert in process validation and regulatory compliance. With a keen eye for detail and a deep understanding of industry regulations, she ensures that all processes and equipment meet the highest standards. Lauren's expertise extends to implementing the latest MoCRA requirements, making her an invaluable asset to clients seeking to stay ahead in a rapidly evolving regulatory environment. Her proactive approach and dedication to quality make her a trusted advisor in the field.

Ready to elevate your quality management systems?

Contact us today to schedule a consultation and discover how our tailored solutions can meet your unique needs. Let's work together to build a culture of quality and compliance in your organization