pattern

Why DifGen

Choose DifGen for our dedication to timely delivery, inventive solutions, and strategic acumen that ensure a competitive edge in the pharmaceutical field. Our skilled teams and comprehensive IP strategies deliver superior and tailored solutions for your needs.

TopBannerTopBanner
on-time-icon

On-time delivery

on time delivery

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.

solutions-focused-approach-icon

Solutions-Focused Approach

solutions-focused-approach-image

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.

highly-experienced-icon

Highly Experienced Cross-Functional Teams

experience

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.

portfolio-icon

Portfolio Identification, Management, and IP Strategy

portfolio-image

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.

You might also like

2024-08-27 00:00

27 Aug, 2024

RMMS Secures Non-Infringement Win on ZTLido® (lidocaine topical system) 1.8%

2024-03-18 00:00

18 Mar, 2024

DifGen Acquires FDA-Registered Manufacturing Facility

2023-04-25 00:00

25 Apr, 2023

DifGen Pharmaceuticals Acquires Aveva Drug Delivery Systems Inc

Your privacy is important for us.

We use cookies to enhance your experience when visiting our websites: performance cookies show us how you use this website, functional cookies remember your preferences and targeting cookies help us to share content relevant to you. Select “Accept all” for giving your consent to all cookies, select “Cookie settings” for managing the different cookies or select “Reject all” for using only strictly necessary cookies. You can change your cookie settings at any point of time by pressing the cookie settings link on the website.