SUNNYVALE, Calif., March 7 /PRNewswire/ -- Conformia, the market leader in enterprise solutions for the life sciences and beverage alcohol industries, today announced the appointment of Vineet Gulati to the newly-created position of Managing Director, FDA-Conformia CRADA Research Study. A senior life sciences and biotechnology industry executive with more than 17 years in pharmaceutical development and commercialization including product operations, supply chain planning, execution, logistics and information technology strategy experience, Gulati will be responsible for providing insight and analysis to data generated through Conformia's Cooperative Research and Development Agreement (CRADA) with the FDA.
"Vineet's depth of knowledge in pharmaceutical development operations, prior experience in successfully managing consulting relationships with top pharmaceutical companies, and strong management skills will be an asset to the study, enabling Conformia to rapidly digest the wealth of information collected and help drive actionable recommendations back to participating companies in the study," said Anjali Kataria, principal investigator of the FDA-Conformia CRADA and co-founder, Conformia Software.
Gulati's accomplishments in the life sciences and biotechnology industries include a proven track record in establishing and implementing strategic Chemistry, Manufacturing and Controls (CMC), supply chain and quality transformation, product operations and change management programs. He spent nearly 10 years at Capgemini where he held several positions including regional practice lead for the organization's life sciences program, as well as the lead for the operations (CMC, Supply Chain, and Quality) consulting discipline within life sciences with responsibility for creating partnerships with leading solution vendors.
Currently the FDA-Conformia CRADA Research study is based on research from nine blinded pharmaceutical and biotech companies which each have multiple products on the market and multiple points of interactions with the FDA. The study's focus is to understand the challenges and opportunities along the development lifecycle with a specific focus on how companies are adopting principles contained within International Conference on Harmonization (ICH) Q8 and Q9 such as Quality by Design, PAT and Design Space
"Both FDA and participants in the study are grappling with understanding the key concepts of ICH Q8 and Q9 and how best to implement these principles in novel ways to support Quality by Design across their development processes," said Kataria. "Vineet's focus will provide the study with a strong framework through within which we can deliver the insights, and build these learnings into best practices examples that companies and FDA are calling for as an important step in understanding how to more effectively build more quality into their development processes and receive regulatory flexibility from the agency."
About Conformia
Conformia Software is the market leader and innovator in providing enterprise software solutions for Development Operations in Pharmaceutical Industry. Conformia's enterprise software enables pharmaceutical development organizations to cost effectively deliver the pipeline, reduce inefficiencies, and drive compliance across the product/process development lifecycle. Conformia is an SAPendorsed business solution for Pharmaceutical Development Operations, and together SAP and Conformia are building a bridge to support the product/process lifecycle from Development to Manufacturing.
NOTE: Conformia is a trademark of Conformia. All other brands, products, or service names are or may be trademarks or service marks of their respective owners.
ConformiaCONTACT: Marc Gendron of Trainer Communications, +1-559-326-2037, orconf@trainercomm.com, for Conformia
