Worldwide scientific regulatory strategies

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Beckloff Associates offers a customized global approach to product development to meet the complex regulatory environments that exist throughout the world. Our strategy is characterized by attention to detail in the preparation of regulatory documents, while considering the current guidance documents of the FDA and the International Conference on Harmonization (ICH). This strategy has reduced development time and accelerated the movement of new products to worldwide commercialization.

We have long-term interactions with all regulatory divisions within the FDA, including the Center for Drug Evaluation and Research (CDER), the Center for Biological Evaluation and Research (CBER), and the Center for Device and Radiological Health (CDRH). In addition, we have broad experience working with U.S. Pharmacopoeia (USP), European Directorate for the Quality of Medicines (EDQM), European Agency for the Evaluation of Medicinal Products (EMEA), Canadian Therapeutic Products Programme (TPP), U.S. Adopted Names (USAN) Council, and World Health Organization (WHO).