Why DifGen

Our Company prides itself on on-time delivery through carefully thought-out robust execution, ensuring first-cycle approval and a strong focus on reducing the number of queries and response times.

Our proactive troubleshooting approach includes a comprehensive global development plan with a common development pathway, a product-specific white paper detailing key scientific and regulatory requirements, and a dosage form-specific regulatory deficiency database to address potential challenges effectively.

Our highly experienced cross-functional teams excel in portfolio ideation by assessing feasibility, complexity, and strategic analysis. This includes evaluating costs and timelines. They bring multi-disciplinary expertise across various dosage forms and markets, ensuring seamless cross-functional integration. There is a strong emphasis on on-time delivery.

Our portfolio identification, management, and IP strategy streamline the process from ideation to launch, addressing complexities in API, formulation, IP, bio studies, and manufacturing. This approach secures a competitive edge through low competition, early entry, low COGS, and supply continuity. We manage entry timing across categories like NCE-1, CGTE, Open FTF, and DESI while pursuing 505(b)(2) opportunities and unique strategies. By leveraging global opportunities and robust IP strategies such as invalidation and FTO analysis, we drive innovation and maintain portfolio advantages.