Santoshkumar Dube

Q: What is Santoshkumar Dube email address?

Email Santoshkumar Dube at santoshdube@gmail.com. This email is the most updated Santoshkumar Dube's email found in 2026.

Q: How to contact Santoshkumar Dube?

To contact Santoshkumar Dube send an email to santoshdube@gmail.com. (updated on November 05, 2024)

Senior Manager Method Development at Zydus Life Science Ltd | Ahmedabad, Gujarat, India

About Santoshkumar Dube

Santoshkumar Dube currently serves as the Senior Manager of Method Development at Zydus Life Science Ltd, where he leverages over 20 years of extensive experience in the pharmaceutical quality laboratory sector. His expertise spans a diverse range of dosage forms, including small molecules, and he has successfully developed and validated over 120 analytical methods. Santoshkumar's proficiency in preparing specifications for both drug substances and drug products, in alignment with ICH guidelines, underscores his commitment to maintaining the highest standards of quality and compliance in pharmaceutical development.

In his current role, Santoshkumar plays a pivotal part in evaluating Abbreviated New Drug Application (ANDA) submission requirements, particularly focusing on In-Vitro bioequivalence approaches. He collaborates closely with cross-functional teams to discuss potential testing parameters, ensuring that all analytical methods and specifications meet regulatory expectations. His responsibilities also include the meticulous review and approval of study protocols, laboratory reports, and standard operating procedures, as well as eCTD documents and other Chemistry, Manufacturing, and Controls (CMC) documentation essential for ANDA and regulatory submissions.

Santoshkumar’s technical acumen is complemented by his hands-on experience with High-Performance Liquid Chromatography (HPLC) and Good Laboratory Practice (GLP) standards. He is adept at troubleshooting analytical methods and instrument failures, which is crucial for maintaining operational efficiency in the laboratory. His leadership skills are evident in his ability to guide and mentor teams in analytical method development and validation for drug products, ensuring that Zydus Life Science Ltd remains at the forefront of pharmaceutical innovation and quality assurance. Through his dedication and expertise, Santoshkumar continues to contribute significantly to the advancement of pharmaceutical sciences, driving successful outcomes in drug development and regulatory compliance.

Santoshkumar Dube Work