Reglera

Who We Are

Reglera is a regulatory compliance and quality assurance consulting and process outsourcing company with offices located in the United States and Israel. Serving both the medical device and tissue banking industries, Reglera’s clients range in size and scope from small start-ups to large multi-national companies. Reglera can provide comprehensive regulatory and quality solutions for its clients in the form of full factory, from the ground up quality systems, or can provide knowledgeable support for specific projects on an as-needed basis.

Whether you are developing a new product, improving an existing product, or simply trying to comply with the myriad of regulations and standards, Reglera’s products and services will accelerate your success and profitability. We accomplish this through a combination of core competencies including

• Quality Systems Development
• Design Control and Structured Development
• Strategic Operations
• Regulatory Submissions
• Compliance Assessments and Audits
• Compliance Remediation

Utilizing best practices and many years of building quality and regulatory systems in regulated industries, we have developed specific consulting services and outsourcing products to help meet your regulatory requirements.

With our unique combination of regulatory expertise and operations knowledge, our teams deliver results that combine regulatory compliance and process efficiency. We do not solve your regulatory problems by installing the quality system over the top of your business system. At Reglera, we know that the most effective way to sustain business success is to combine business and quality requirements into a single, efficient system.

A Different Approach

Our approach to your project is unique in our industry. Most consulting services and service products are delivered solely on a time and material (T&M) basis. Reglera, however, performs a detailed analysis of your needs in the beginning to establish clear deliverables and schedules and then quotes your projects on a fixed bid or blended (fixed and T&M) basis. This allows you to firmly establish your budget and plan accurately for the completion of the project. With Reglera, you know up-front what to expect at the end of the project, ensuring you receive desired results without surprises.

• Decreased time to market with compliant, approved products
• Significantly lower compliance costs through systems that meet both business and regulatory requirements
• Decreased overhead costs and increased productivity, flexibility, and availability
• Lower operational and product costs through efficiency improvements and outsourcing of non-core processes
• Retention of core intellectual property and competencies

All of our products and services come with a guarantee that if they receive any FDA observations, we will respond to FDA and fix the problem at no cost to the customer.