ST&R can assist you with your prescription (Rx) or over-the-counter (OTC) pharmaceutical product by providing the following services:
- submission and advisory services regarding need to submit new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for generic drugs
- compliance with published monographs for over-the-counter drugs
- counseling clients on good manufacturing practices, labeling and advertising matters, conducting product recalls, responding to warning letters and managing FDA inspections
- compliance with requirements for importation of pharmaceuticals from foreign manufacturers
- registration of manufacturing facilities and application for NDC numbers
- development of regulatory strategies for implementing novel business approaches
If you require assistance with your prescription or OTC pharmaceutical product, please contact Edgar J. Asebey-Birkholm at
easebey@strtrade.com or at (305) 913-3902.