505(b)(2)-Generic Hybrid

Development of new or different formulations for known drugs is now a very interesting asset in R&D and clinical research. Drug products being submitted under section 505(b)(2), sharing similarities with both the 505(b)(1)-NDA and 505(j)-ANDA, have gained in popularity with recent  submissions of 505(b)(2) representing over 50% of FDA’s new drug approvals. 

As a global leader in scientific, clinical and bioanalysis research and through key alliances critical to this sector, our team of experts can help you design and conduct your study successfully through the following services:

• Recruitment
• Clinic 
• Data Management
• Project Management
• Scientific Affairs
• Regulatory Affairs
• Bioanalytical Services
• Quality Assurance
• Statistical Services