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Worldwide scientific regulatory strategies
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).
Our service offerings include:
Regulatory Support
- Liaison to Regulatory Authorities
- Interactions with Regulatory Authorities regarding project-specific issues or current position on certain issues
- Interactions with Regulatory Authorities to coordinate current Good Manufacturing Practices (CGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) FDA inspections, including follow-up correspondence and documentation
- Meetings with Regulatory Authorities regarding drug development programs (i.e., pre-IND, end-of-Phase 1 and 2, pre-NDA, and Advisory Committee meetings), including meeting organization, information package preparation, and meeting management
- Regulatory guidance at all stages of product development
Scientific Regulatory Affairs and Regulatory Documentation
- Drug Master File (DMF) Preparation and Maintenance
- Chemistry, Manufacturing, and Control (CMC) Documentation Preparation for Drug Substances and Finished Formulations (IND, NDA, ANDA, NADA, NDS)
- Investigational New Drug Application (IND), Amendments, Safety Reporting, and Annual Reports
- New Drug Application (NDA), Amendments, and Supplement Annual Reports, and Postmarketing Reporting
- 505(b)(2) NDA Application, Amendments, Annual Reports, and Postmarketing Reporting
- Abbreviated New Drug Applications (ANDA), Amendments, Safety Reporting, and Annual Reports
- Common Technical Documents (CTD)
- Electronic Submissions
- International Regulatory Submissions (EDMF, CDMF, IND, NDS, Certificate of Suitability)
- Premarket Notification Application (510(k)) preparation
- Investigational Device Exemption (IDE) preparation and maintenance
- Prescription drug and over-the-counter drug labeling preparation
- Orphan Drug Designation Request (ODDR) preparation and maintenance
- Fast Track Requests preparation and maintenance
- Biologics License Application (BLA) preparation and maintenance
- United States Adopted Name (USAN) Application preparation
- Product Registration
- Establishment Registration
For capabilities that will meet your needs, and outcomes that will exceed your expectations, partner with Beckloff Associates today. For more information, fill out our Contact us form or call a member of our sales staff at 913.451.3955.
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