Regulatory affairs
Whether you realize it or not, you cross paths with the regulatory affairs industry on a daily basis. Each food, beverage, cosmetic, prescription medication, or vitamin you purchase has undergone rigorous regulatory checks for safety and efficacy on its path to supermarket shelves…
Sercotech Regulatory affairs
Regulatory checks for safety and efficacy
But it’s not just food and prescription drugs that need to be approved for human consumption. All medical technologies, including medical equipment, implanted devices, and biotechnological advancements, are also subject to federal and international regulation to ensure their safety, efficacy, and performance.
Despite these stringent regulations, the rapid development of new medical technology and the increasing accessibility of food from around the globe introduce new risks to the market daily. Thus, it is now a global imperative to develop and improve state, federal, and international regulations to maintain the innovation and release of food and biomedical products to global markets. To do this, we rely on the expertise of regulatory professionals.
Our regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development.
In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
SERCOTECH regulatory professionals are also often a voice in conversations at the cutting edge of health and public policy.
