Not only are vendor audits/assessments imperative for assuring quality product, vendor qualification is a top focus in FDA now. Reliant can develop a cost-effective and compliant program for assuring vendor performance, as well as perform the vendor auditing and qualification itself, all for less than it costs to perform these tasks in-house.
Warning Letter and 483 Responses
Avoid costly and time consuming back and forth with the agency due to insufficient commitments in the eyes of FDA. Why hire a law firm to address this task, when Reliant can ensure a quick and comprehensive response to any 483 or Warning Letter? Not only will our response save you time and money upfront, Reliant provides knowledgeable insight as to what the agency is expecting to see in an adequate response to the issues presented.
This is one of Reliant’s core service offerings and what we have become to be known for. Anyone can claim to have hands-on knowledge about process validation, equipment qualification, cleaning validation, and even computer system validation. However, knowing how to write the test and execute the test in order to prevent commonly encountered pitfalls is the key to success. 25% of overall facility costs are associated with validation activities. Don’t let the money you spend become a wasteful effort.
Know how to correct an issue but still getting cited for not having a solid preventive action? Reliant can develop a procedure for CAPA handling and help you to close out existing CAPA investigations that meet regulatory expectations and are sustainable within your organization.
Regulatory Agency Submissions
Got a 510(k), Structured Product Labeling (SPL) for Electronic Drug Listing, Drug Master File (DMF), Abbreviated New Drug Application (ANDA), State Department of Health (DOH) License, or other submission to FDA or a state agency? Let us get it submitted and through the regulatory hurdles faster, so you can concentrate on getting the product to market faster.
Due Diligence Assessments
Don’t rely on the dog and pony show when looking to purchase a company in the FDA regulated industry. Reliant can quickly get to the root of the company to assess both compliance AND operational aspects of the organization to help ensure that what you are paying for the company takes into account the modifications to the operation that may be required.
Calibration and Maintenance Programs
Don’t have the funds to purchase and validate a fully 21CFR Part 11 compliant calibration or maintenance software package? We can help! We have help implemented numerous cost-effective packages and even paper-based systems that have not only passed regulatory inspection scrutiny, but that are also easily sustainable for any organization.
Design Control Programs
Design control requirements are probably the most misunderstood aspect of the medical device industry. We can develop a simple program for you to follow or assess your existing program to see if your interpretations of the requirements are in compliance with what the agency currently expects.
Whether it be handling of out of specification (OOS) results, operation and maintenance of your purified water system, or handling customer complaints, Reliant is single source for generating standard operating procedures (SOPs) that are accurate and customized for your company in order to both facilitate training and to ensure consistent operations.
Contract Project Management
Need that project to come in on time and within budget? Hire Reliant’s project management services to get it done. How good are our project managers? We have been hired by clients on more than one occasion to manage projects being executed onsite by other compliance consulting organizations! Reliant ensures that projects stay on track from beginning to end.
Looking to avoid paying for employee travel associated with training/seminars? Looking to keep your cGMP training on track annually as per regulatory expectations? Looking to keep the topics current, applicable to your company’s operations, and interesting for your employees? Then, Reliant is your training services provider. We do not charge per head or require that your employees take days off to attend sessions out of state. Reliant comes to your facility and provides hands-on training on many topics for as many of your employees that can fit in the room for one flat fee. We customize every training sessions to match your specific operations, and document the training for you, so that full benefits are experienced from the sessions.
Label and Promotional Material Review
How can I say what I want to say on my product labels and marketing materials without risking regulatory action? Are product claims on our company website acceptable? These are just a few of the questions Reliant receives daily with regards to label claims and marketing material compliance. We know how you can get across your message without having to take all the “meat” out of your marketing message.
Expert Witness Services
Reliant’s expert witness services not only provide technical expertise to your case, but we also are known for being able to express confidence in direct testimony and under cross-examination as well as being able to simplify complex topics to get the point across quickly.
If your company is in the seafood industry, then you know about the Hazard Analysis and Critical Control Points (HACCP) regulations. Let us develop a program for you that is not only compliant but sustainable within your organization.
Mock FDA Inspections
As one of our top requested services, our mock FDA assessments (i.e. inspection readiness) are a great way to initiate a project with Reliant and get a top to bottom assessment of where your organization stands from a compliance perspective. Not only do we address every aspect of your operation, we also provide a detailed report containing not only the observations, but the risk-level associated with each observation. However, that is not all! We also detail specific recommendations on how to implement the most cost-effective corrective actions for each and every observation noted.