Regulatory expertise is an absolute necessity in the biomedical marketplace. The medical technology industries can no longer afford a layered systems approach to achieving regulatory compliance. Organizations in regulated industries need to possess expertise, at a low cost, in order to successfully integrate their operational and regulatory requirements into holistic, efficient systems. However, balancing this need with the cyclic nature of the work combined with limited expertise often results in poor resource utilization.
Each outsourced product is validated per FDA regulations, providing you a high level of regulatory security while not requiring any up front capital investment. From outsourcing key areas to complete regulatory compliance solutions, Reglera provides internal specialists and a national network of qualified experts to meet your needs. The Reglera team is comprised of seasoned professionals from the medical device and tissue banking industries with decades of experience dealing with the FDA both at the district and national levels.
Reglera has identified the following key operational areas where unique systems are built to deliver optimal results at the lowest cost and maximum resource utilization:
Electronic Document Change Control System
Easily locate and organize your crucial procedures and quality records through an efficient, secure and cost effective electronic document management system. Reglera's turnkey system provides a web-based, validated, secure system to index, manage and control all types of documents.
Complaint Handling and Adverse Event Reporting
Our automated, customized and personalized complaint handling solution is designed to efficiently handle customer complaints in a professional manner and take appropriate action. This service is customized for each customer and ensures consistent and timely documentation, investigation, and corrective action to ensure regulatory compliance.
Supplier and Internal Audit Programs
We can implement a system that ensures your audits are not only meeting your current compliance needs, but also are updated to leave room for continual improvements. By utilizing our auditing resources instead of hiring additional staff, you will save both time and money. We review and set an annual audit schedule to ensure that appropriate resources are available where and when they are needed.
Managed Validation Programs
Reglera's national network of expert validation engineers is unparalleled in the industry. We work with each client to set up a validation schedule based on appropriate regulations and standards to ensure each process will achieve consistent, repeatable results with the least amount of variation.
Training Records Management
Ensure your training records are up to date with your policies and procedures through this unique system that is integrated with our Document Change Control System. This system electronically notifies individuals and supervisors of new training requirements and allows you to view your individual or corporate-wide compliance status.
Reglera's approach to providing compliant outsourced solutions is unique to the industry. All of our outsourced products 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.
