At the end of the day, it's up to pharmaceutical executives to ensure medical products are approved by the appropriate agencies and marketed appropriately.
However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency.
At best, not following these regulations result in submissions not being approved or approval being delayed along alongside revenue dips and increased costs. At worst, it can result in a company receiving warning letters and being subject to other disciplinary actions.
With these challenges in mind, many pharmaceutical executives choose to enlist the expertise of a consulting firm that specializes in compliance with regulatory guidelines.
Firms like these provide a variety of regulatory services that enable executives to get pharmaceutical products on the market more quickly, ensuring that the appropriate regulations are followed.
Why Consult an FDA Compliance Firm?
Since many pharmaceutical companies have their own quality assurance departments, many executives wonder what these firms can do for them. Here are a few ways compliance consultants can help:
1. Keeping closer track of constantly changing regulation guidelines
Depending on the size and scope of your in-house team, executives and quality assurance personnel often have difficulty keeping abreast of all the changes and developments that are constantly going on in the regulatory world.
Compliance and regulatory consultants are keeping track of these developments everyday. Here at The FDA Group, we work with a number of former FDA staff and a variety of other industry experts that have intimate knowledge and experience within the FDA and other agencies.
2. Filling quality assurance gaps for start-up companies
For those at the helm of a new startup company who many not be as familiar with the FDA's guidelines, compliance consultants can lend their expertise in the particular fields you're working in, saving valuable time and energy that can be focused on growing the company instead.
3. Getting a fresh perspective on proper adherence
Even when executives are well-versed on current guidelines, consulting a compliance firm can provide a fresh perspective on how to adhere to FDA regulations.
For instance, compliance firms can help executives to determine the most cost effective approach for complying with the regulations, the most applicable regulations for the products that the company manufactures, and strategies for complying with the guidelines.
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Want to learn more about the benefits of working with experienced FDA compliance consultants? Read our free white paper: The Benefits for Pharma Companies of Working with an FDA Compliance Consulting Firm