Many companies believe that well-thought-out FDA regulatory strategies have no place in the process of getting FDA-approved and maintaining their FDA compliance. However, our experience in the industry has helped us to know otherwise and to understand that these are actually shaped by an interplay between the product development process and FDA submission process. Because of this, we at VZG can help you craft a regulatory strategy that is tailored to your specific situation, including documentation, submission processes, and proprietary measures for clinical trials.
Ensuring that your organization complies with all of the FDA quality system requirements is critical. However, because the process of FDA compliance varies greatly for each company, it is vital that you put careful thought on these kinds of decisions and their planning. Otherwise, they will have an impact on the speed and cost of your company’s implementation, as well as on your potential savings and the speed of your FDA approval process.
Quality System Implementation Services
At VZG, we can help you prepare and implement the entire quality system for FDA Quality System Regulation (QSR) or Current Good Manufacturing Practices (cGMP) compliance. From quality manual and quality procedures to work instructions, product quality plans, and production-level quality records, we can assist you in implementing a quality system that is customized for your operations.
cGMP Audit Services
As a recognized FDA expert, VZG can provide you with a mock FDA audit that is similar to what you would expect to receive from the FDA and is performed in a similar manner to an FDA audit. This FDA audit of your company’s operations may help you determine the degree of your compliance with the FDA cGMP so that you can test your quality system and take the appropriate measures for corrective actions.
FDA Validation Guidelines
VZG has professional staff who can put together and execute complete validation protocols for your organization. Aside from that, we can also interpret the data to check if they meet with the FDA guidelines. Our validation services observe the FDA’s Analytical Method Validation (AMV) and Analytical Instrumentation Installation and Operational Qualifications.
We provide FDA cGMP in-house employee and internal auditor training programs that have been customized to your products and operations. Our training services cover all aspects of FDA quality system requirements and regulatory requirements, including cGMP compliance, dealing with FDA inspections, FDA strategic planning, and preparing replies to Warning Letters, among others.
FDA Liaison Services
As an organization that has successfully navigated through a number of FDA inspections both locally and internationally, we know the challenges involved in dealing with the FDA, especially during an inspection that could prevent product commercialization. We can also assist you if you would rather expedite the inspection.