Good Manufacturing Practices compliance is one of the best ways to show that your manufacturing company puts the quality of its products first, and the standard is widely accepted as a pinnacle of excellence. GMPs reflect top-tier manufacturing processes that the FDA oversees. We help your manufacturing company through the procedures for GMP compliance. Our services include the necessary templates, forms, procedural guidelines and more. We also provide thorough training. To help create a system that will benefit you now and in the future, we do the following:

• Full audits of manufacturing plant floors for GMP compliance.
• Comprehensive reporting.
• Suggestions for facility improvement in all applicable areas.
• Review of GMP non-compliance issues associated with the facility.
• Strategic planning for improved compliance measures.
• Drafting replies to the FDA in response to any Warning Letters and 483s that you may receive.

When we develop strategic plans, they may include new manuals, forms or other organizational documents for your company. Updating procedures, rules and other information is important for maintaining future compliance and properly training workers. If these aren't updated, there can be confusion or miscommunications that can lead to problems.

We are dedicated to working closely with your company and the staff throughout the entire process. This gives you the chance to ask questions and have continual help through the execution of the plan. One of the reasons why our services and involvement are so intensive is because this reduces the chances of a company that we help getting a citation from the FDA in the future.

One of the important points that we tell the manufacturers who work with us is that the cGMPs are only minimum standards. When there are ways to exceed these standards for strategic purposes, consultants can find them. In some cases, they may also be able to predict an upcoming change and develop a strategy for it in advance. 

The cGMPs are somewhat flexible to fit a variety of processes, and we show you how they apply to your unique processes or procedures. With our help, you have skilled guidance for developing the right systems and control measures that are strong and reliable. These are the three key benefits of using our consulting services.

Advocacy

Government organizations are known for publishing long guides that explain their rules with jargon. Those manuals and guides can be difficult to understand if you're new to such regulatory issues. Also, the FDA won't work with you closely through every step. We serve as your advocates and are there with you every step of the way. The FDA doesn't have anything invested in your success. However, we invest research, analysis and plenty of time in your success. Since your success helps us as well, you can enjoy more peace of mind and confidence.

Expertise

Since we are familiar with every detail of cGMPs and stay current on changes, you know that you're getting reliable information and help. Our methods are sound, tested and successful. We also stay current with technological trends and find innovative ways to integrate them for maximized efficiency. 

Excellence

With our thorough consulting services, we leave you with a facility that is in excellent condition, reliable processes and reporting, equipment that is carefully monitored and workers who are qualified to maintain plans. This gives you the confidence you need to offer assurance of top quality to your buyers and to stand behind it.

When it comes to the FDA or other government organizations, there is no room for errors or setbacks. We provide practical and thorough GMP and cGMP consulting to pharmaceutical companies, makers of medical devices, dietary supplement makers and other related companies. Our consultants are experienced and know how manufacturing plants work as well. Rest assured that we can help you plan, execute and maintain systems that are efficient and fully compliant.