Syner-G BioPharma Group
Lata Harish has a diverse work experience spanning over three decades. lata currently holds the position of Associate Vice President QA at Syner-G BioPharma Group since January 2023. Prior to that, they worked as a Freelance Auditor and Consultant from January 2021 to December 2022. Lata also served as Lead QMS and Master Data at Tenshi Kaizen from January 2019 to January 2021. Before joining Tenshi Kaizen, they worked as Assistant Vice President QA at Stelis Biopharma Pvt. Ltd. from March 2012 to January 2019. Their previous experience includes being the Head QA at Strides Arcolab Pvt. Ltd. from March 2000 to March 2012, QA & RA Executive at Micro Labs Limited from August 1997 to February 2000, Production Executive at Cipla from November 1993 to October 1996, and Quality Assurance Officer at Techno Chemical Industries Pvt. Ltd. from August 1991 to October 1993.
Lata Harish has pursued an Executive MBA from IIM, Bangalore. Prior to that, they completed their Bachelor of Science in Chemistry and Master of Science in Biosciences from JMI, New Delhi. Additionally, they obtained a certification as a Certified Lead Auditor for Quality Management System - ISO 13485-2016 from the British Standard Institute. No specific details regarding the start and end years of their education or the month and year of their certification have been provided.
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Syner-G BioPharma Group
Syner-G BioPharma Group provides in-depth expertise across the three key elements of Chemistry, Manufacturing, and Controls (CMC): Regulatory Services, Technical Development, and Quality/IT. We call this CMC 360™. We also provide medical writing services, with expertise in authoring a variety of regulatory documents across a wide range of therapeutic areas and in all phases of development. Our regulatory affairs services include the development and implementation of global regulatory strategic plans, regulatory agency meeting support, and electronic submissions to regulatory authorities around the world. We have the skill set and experience to guide your prime asset through any development challenges and along the ever-changing maze of regulatory filing pathways, to a position of full compliance, and high quality. Our expertise spans small molecules, peptides, oligonucleotides, biologics, monoclonal antibodies, antibody-drug conjugates, and cell and gene therapy products.