Gul Balwani

WORK HISTORY

EDUCATION

SKILLS

ABOUT GUL BALWANI

Leadership of various pharmaceutical development programs with extensive skills and expertise in the strategic planning and project management of pharmaceutical and biopharmaceutical product development from pre-clinical development, clinical program management, through commercialization for large international as well as small domestic and virtual companies. Experience with small as well as large sized molecules from various therapeutic areas for the development of formulations and dosage forms as well as novel drug delivery systems resulting in numerous patents. Development of manufacturing processes using PAT and QbD principles, scale-up and transfer of technology to global manufacturing sites including CMO\'s. Extensive knowledge of US and European Regulatory Guidelines and Requirements. Development of Regulatory CMC Documents to support drug applications. Excellent project management skills, scientific expertise with business acumen, cross functional team leadership and communication skills.Provided team leadership in managing CMO\'s resulting in successful PAIs and drug product approvals. Authored PD & TT reports. Experienced in vendor selection, contract management, and contract negotiations (LOI, development, supply, and quality agreements) for clinical and commercial manufacturing. Successfully built, led and managed various project teams, managed resources to ensure timely implementation of planned activities to accomplish corporate goals and objectives within the constraints of time and cost. Provided training and development to team members and direct reports.Specialties: Pharmaceutical Product Development