Our scientists have been a welcome part of product development expeditionary teams for decades. For clients with novel products we have investigated prevailing regulatory environments and advised on the risks of various paths through the woods. Advise on European and U.S. Registration Strategies Plan submission Coordinate multiple submissions for products developed simultaneously in Europe and North America Investigational New Drug Exemptions Investigator's Brochures Package Inserts, including Annotation New Drug Applications Master Files Annual Reports Abbreviated New Drug Applications Summary Bases of Approval Establishment License Applications Product License Applications Orphan Products Applications EEC Re-Registration Documents German Data Forms Documents for Drug Registrations outside of the United States: Benelux, Canada, France, Germany, Italy, Nordic countries, United Kingdom, European Community