Embarking on the journey to FDA Approval can be frustrating and disappointing when the task is left in the wrong hands. Groupe Athena has a commitment toward each of our clients to provide the highest quality services and the most positive outcomes at the least expense to our clients. With unmatched knowledge of the FDA Approval Process, as well as experience and knowledge of the cultures in which we conduct our business, our consultants are ready to serve you.
Our services offer an initial consultation to enable us to plan and strategize with goals specific to your product or company’s needs. We deliver comprehensive consults throughout the inspection process including mock FDA inspections and mock product recalls to identify and solve breaches in compliance through assessment and modification. With the right knowledge about supplier audits, document preparation and filing processes, we are able to meet all regulations and requirements. We also provide guidelines to ensure quality throughout development.
Whether you are seeking FDA approval for biotech products, pharmaceuticals [OTC, prescription or generics], diagnostics, or medical equipment and devices, we have the quality resources to know what is needed during each step of the process to guide you through it and to qualify. Our past and existing clients know their needs are met by professionals, who put client satisfaction as their number one priority.
Groupe Athena takes seriously, the processes and strategies to obtain FDA Approval on behalf of our clients, and we are proud when subsequent approvals lead to medical breakthroughs and economic prosperity on all sides of the world.