Our focused product development process is integral to successful commercialization.
Working as a Team
"The best part of the day is when I am working with my team, making decisions, making sure that everyone is on board, making sure that everyone is excited to move forward. Wael - Business Development"
Our product development process is based on a Quality by Design (QbD) paradigm.
We incorporate characterization of the drug substance and inactive ingredients, identification of critical manufacturing process parameters (CPP), understanding of the drug product behavior, performance (Q1/Q2/Q3) and stability to establish the QTPP and CQA for product life cycle management.
Each product development is an improvement over the last, as we stay aligned with the evolving global regulatory standards, and meet current filing expectations from the FDA.
Our product development team includes formulation and analytical scientists. Through reverse engineering, method development and process optimization, our product development team supports regulatory submissions for our pipeline of topical, injectable, complex and ophthalmic products.