Gul Balwani

Gul Balwani is a seasoned professional with a strong background in pharmaceutical product development, strategic planning, and project management across various therapeutic areas and product types.

With a wealth of experience in leading pharmaceutical development programs for companies of all sizes, Gul has expertise in pre-clinical development, clinical program management, and commercialization processes.

Gul's skills extend to the formulation and dosage forms of small and large molecules, as well as the development of novel drug delivery systems, resulting in multiple patents.

Proficient in manufacturing processes utilizing principles such as PAT and QbD, Gul has successfully scaled up technologies and transferred them to global manufacturing sites, including contract manufacturing organizations (CMOs).

Gul's knowledge of US and European Regulatory Guidelines and Requirements is extensive, with a track record of developing regulatory CMC documents to support drug applications.

As an adept project manager, Gul possesses scientific expertise paired with business acumen, fostering effective cross-functional team leadership and communication within organizations.

Throughout Gul's career, there have been successes in managing CMO relationships leading to successful PAIs and drug product approvals, along with authoring PD & TT reports and overseeing vendor selection and contract negotiations.

Gul has demonstrated excellence in building, leading, and managing project teams, ensuring the timely implementation of activities to achieve corporate objectives while providing mentorship and development opportunities for team members.

In addition to a strong professional background, Gul Balwani holds degrees in Pharmaceutical Chemistry and Industrial Pharmacy, with additional certifications from prestigious institutions like Harvard Business School and Massachusetts Institute of Technology.