ACCESSING THE AMERICAN MARKET
We assist companies with understanding the rules and accessing the American consumer market. Through our partner network, you will also have access to highly specialized FDA resources.
Medical Consulting, including 510(k) applications
We offer consulting on the regulatory, clinical, quality and statistical aspects of drug, biologic, diagnostic, and medical device development. The major focus of our services are related to product approval support. Services include the following: regulatory and clinical strategies and implementation for pre-market submissions, pre-clinical and clinical study design, protocols, monitoring, clinical auditing, data entry, database management, statistical analysis and evaluation, report writing and training. We can also assist companies in setting up Design Controls, ISO and GMP compliance programs.
FDA Legal Services
We offer regulatory and intellectual property counsel to food, dietary supplement, drug, biologic, medical device, and cosmetic companies in the research, development, approval and promotion of their products in the U.S. and international markets.