FDA Compliance Services for the Pharmaceuticals Industry
FDA Regulatory Strategy
Several firms believe that meticulously planned FDA regulatory strategies do not do much when it comes to FDA approval and maintaining their FDA compliance. However, being in the industry for years have taught us that there is an interplay between the product development process and the FDA submission process. Because of this, we at VZG can help you with the following:
Maximizing your product revenues by giving you opportunities to sell your product even when the FDA is still reviewing your files;
Minimizing the time it takes for you to submit the necessary documents by indicating the steps necessary for you to prepare and submit your documents correctly;
Minimizing your expenses in the submission process by setting up a specific roadmap that can help you identify the steps necessary for the proper submission of your documents, eradicate clinical trial mistakes, and lessen errors in the implementation of a quality system; and
Optimizing your competitive situation by analyzing how your submission and company structure can affect your competitors, customers, and suppliers.
Clinical Trial Management Services
VZG offers clinical trial management services that help you get ready for market approval. From developing the clinical protocols, setting up an and interacting with the Institutional Review Board (IRB), and submitting the Investigational Device Exception (IDE) to monitoring clinical trials, gathering and analyzing data, and managing the entire project, we will work closely with you so as to help you obtain FDA’s approval quickly and inexpensively.
ANDA/NDA/DMF Submission Services
There are documents that must be submitted by pharmaceutical companies before they can successfully market their medical drugs in the U.S.
An Abbreviated New Drug Application (ANDA), for instance, consists of data that pertains to the review and final approval of a generic drug. Consequently, it is necessary that pharmaceutical companies submit this form before they can manufacture and market the generic drug in the U.S. On the other hand, A New Drug Application (NDA) is the method through which drug sponsors formally approach the FDA for the approval of the sale and marketing of a new pharmaceutical in the U.S. market while the Drug Master File (DMF) application contains confidential, detailed information about the facilities, ingredients, and processes used in the manufacture, processing, packaging, and storage of a concerned drug. This document is used to review an ANDA/NDA application.
Many companies planning to introduce their pharmaceuticals in the U.S. market have had unforeseeable difficulties in the preparation and submission of some of these documents. If you are one of them, VZG consultants may be of assistance to you. Our staff have in-depth knowledge on how to prepare and submit your required documents.
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.
There are mainly three kinds of validation we can help you with. For process validations, we can help you prepare and implement your validation protocols, as well as interpret the data gathered in order to meet with the FDA guidelines. If you’re looking for assistance in sterilization validation, we can also review the installation qualification documentations from your vendor, or prepare the protocols for performance qualification and validate the protocol processes. Our software validation assistance also enables us to conduct a validation of your protocols preparation, hazard analysis, and review, among other services.
Furthermore, we can also interpret the data you have collected to see 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