We Help Your Company Achieve and Remain in Regulatory Compliance
There are a whole host of standards and regulations that medical device and pharmaceutical manufacturers must adhere to in order to maintain compliance market their products. When operating within a constantly changing regulatory landscape, companies may find it challenging to keep up with and meet new guidelines and/or regulations coming from the FDA, international regulatory bodies, as well as industry groups.
Are You Prepared?
Sometimes, the regulations aren’t clear or worse, they are open-ended, leaving much to interpretation. These differences in interpretation between agency/notified body representatives and company representatives requires strategy, preparedness, and a logical defense on the part of the company.
QSCS can work with you proactively to establish that defense prior to any “visits” and in the event of an inspection, QSCS can assist you in audit management and response management if necessary.
We Are Here To Help
When inspections lead to a 483, a Warning Letter, a Consent Decree, or worse, we partner with you, working with the FDA or Regulatory Bodies to develop a strategy and address specific issues to achieve and remain in Compliance
Together We Develop A Strategy
We Help You Navigate Through Product Submission and Approval
In order to protect public health and ensure the availability of high quality, safe and effective medicines, and medical devices, the FDA, the MHRA, and other international regulatory bodies have put together a series of requirements that must be met by companies wishing to market their products. As you can imagine, these requirements can be difficult to navigate which can lead to refusals, ultimately sending companies back to the drawing board. At a minimum, this is a frustrating exercise for the company.
However, while delays in product launch not only cost significant sums of money for the company but also delay much-needed therapies from getting to needy patients. Let QSCS help you avoid those delays.
Let Your Compliance Solution Pay for Itself
The purpose of the submission process is to legally market your products. QSCS will alongside you to submit a comprehensive and compliant set of documentation, putting your product in the best position for acceptance and on the fast track to market. It is our goal to deliver REVENUE NEUTRAL COMPLIANCE.