Please wait...
We offer standards development, certification preparation, auditing, inspection, consulting and training services tailored to your company’s needs. Our scientists and public health and environment professionals support your industry requirements and organizational demands. We have you covered, from product certification, laboratory testing and standards development for the food, water and consumer products industries, to pharma, biotech and medical device training and consulting, to management systems certification and beyond.
Krystol Consulting has the knowledge and expertise to help you determine the correct classification for your device and assist with the production and submission of your application.
In order to make sure you get it right the first time, Krystol Consulting will combine our knowledge and experience to plan and coordinate every detail of a clear and complete FDA submission.
We employ a diverse team of consultants with a variety of expertise and work experience. Former regulators, QA/QC leaders and leading chemists and toxicologists make up our team.
We are a full service, hands-on quality consulting firm specializing in the establishment, implementation and improvement of quality management systems, quality auditing and training.
A quality audit is one of the most effective tools in the ISO and GMP standard toolkit for ensuring a certain level of discipline in performance as well as driving long term continuous improvement.
We customize every ISO and GMP training activity to the exact needs and objectives of our clients. We provide end-to-end training.
Krystol Consulting has the knowledge and expertise to help you determine the correct classification for your device and assist with the production and submission of your application.
Please contact us for more information on device submissions