Season's Greetings from Kamet Consulting Group! As we close out a remarkable year, we want to express our heartfelt gratitude to our clients, partners, and team members for being an integral part of our journey. 2024 has been a year of immense growth for Kamet Consulting Group. We've expanded our talented team both here and in our India office, delivering impactful projects and earning the continued trust of our valued clients. Your trust inspires us to reach new heights, and as we look forward to 2025, we're thrilled to introduce innovative automation solutions designed to support programs focused on rebranding, large-scale transactions/deals, and change management. These advancements reflect our commitment to driving excellence and efficiency for our clients. Thank you for being a part of our success. May your holidays be filled with joy, and may the new year bring you prosperity and new opportunities. A picture of little nugget tree that was felled from our CEO's backyard.
Kamet Consulting Group
商务咨询服务
San Francisco，California 3,446 位关注者
Uncompromising Quality || Relentless Client Focus || Fit for Purpose
关于我们
Kamet Consulting Group provides Strategic Advisory, Implementation, Capability Building, and Outsourced Services to Life Sciences, Food, Digital Health, and Consumer Health companies across the value chain. Headquartered in San Francisco, California with a satellite office in India, Kamet Consulting Group is a management consulting firm delivering customized solutions to food, life sciences, digital health, and consumer health industry at various stages of organizational maturity and multiple geographies. Our practitioners have decades of collective experience in guiding clients through every stage from strategy development to implementation, drawing on our real-world expertise to offer practical recommendations. At Kamet, we are committed to making your success our top priority. Our expertise spans across Strategic Advisory, Implementation, Capability Building, and Outsourced Services within organizational and functional areas of Deals, R&D, Clinical, Regulatory, Quality, Labeling, Safety, Supply Chain, and Commercial. We bring extensive experience and professionalism to every engagement and customize our support to your individual needs and opportunities. At Kamet Consulting Group, we strive to create a strong and inclusive workforce by actively seeking a diverse pool of applicants. We firmly believe in providing equal opportunities to all qualified candidates, without any discrimination based on factors such as race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
- 网站
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www.kametcg.com
Kamet Consulting Group的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 11-50 人
- 总部
- San Francisco，California
- 类型
- 私人持股
- 领域
- Regulatory Affairs and Operations、Deals、Labeling、Quality、Commercial、Supply Planning、Operations、Lifesciences、Pharmaceutical、Medical Devices、Digital Health、Food、Consumer Health、Post Market Surveillance、New Product Launch、Safety / Pharmacovigilance、R&D、Clinical和EU MDR / IVDR
地点
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主要
获取路线
US，California，San Francisco
Kamet Consulting Group员工
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Megha Sinha
CEO at Kamet Consulting Group | Life Sciences Strategy, Transformation, and Operations Leader | Pharmaceuticals | Medical Devices | Digital Health |…
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Ayse Demircan
Senior Consultant at Kamet Consulting Group
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Katherine Popovich, PharmD, RPh
Doctor of Pharmacy
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Sahana Rajashekar
Senior Regulatory Affairs Specialist -II
动态
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We are very excited to be attending Regulatory Affairs Professionals Society (RAPS) Convergence 2024 (#RAPSConvergence2024) and facilitate the evolving space of LDTs. Join our Senior Consultant Ayse Demircan as she shares our perspective and also gather insights as the industey goes through this transition. #LDTs #IVDs #MedicalDevices #Pharmaceuticals #lifesciences Kamet Consulting Group specializes in helping organizations navigate large scale transformations. Please reach out if you are looking to collaborate on LDTs or other topics that might be useful for your organization. #transformation #Deals #LDTs #BusinessStrategy #Automation
Kamet Consulting Group is excited to attend RAPS Convergence 2024! We’re looking forward to contributing to the conversation at our Solution Circle tomorrow (more information here: https://cdmcd.co/gaa5Br ) on Transformative Trends: Navigating the Evolving Regulatory Path for Laboratory Developed Tests (LDTs). This solution circle on LDT regulations is designed to provide participants with profound insights into their impact on the healthcare industry, unique challenges small labs may face, exploring solutions for equitable compliance, and access to quality diagnostic services. We aim to equip attendees with a nuanced perspective within the evolving regulatory landscape. We look forward to engaging with fellow experts and expanding our perspectives in the evolving regulatory landscape. We can’t wait to bring back new insights that will strengthen our ability to support clients navigating these changes. And as always, a big thank you to the organizers for hosting this event! We’re eager to make the most of this incredible opportunity for learning and collaboration. If you’re at RAPS, we would love to meet you and see how we can collaborate together! #RAPSConvergence2024 #LDTRegulations #HealthcareInnovation #KametConsulting #RegulatoryAffairs
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We are excited to have attended Day 1 of 8th Annual Medical Device Regulatory and Quality Summit 2024, and engage with key leaders. Our team is looking forward to Day 2!!
Manager - II at Kamet Consulting Group | Regulatory Affairs | Medical Devices | Drugs | Life Sciences Strategy
Kamet Consulting Group is thrilled to have attended Day 1 of 8th Annual Medical Device Regulatory and Quality Summit 2024, Delhi, India which is conceptualized by Inventicon Business Intelligence. The summit brought together the distinguished dignitaries from the regulatory and policy bodies such as CDSCO, Indian Pharmacopoeia Commission along with the renowned leaders from the global medical device market. The 8th Annual Medical Device Regulatory and Quality Summit 2024 has created a platform for regulators and industry stalwarts to come under one roof to discuss and share ideas that would not only benefit their organizations, but at large the industry as well. We are excited to be a part of this vibrant community and look forward to contributing to the future of pharma and medical device industries. Topics covered on Day 1 are current regulations governing medical devices in India including recent updates and upcoming changes, EU MDR implementation and expectations from the industry, medical device testing in animals and evolving medical device regulations-ensuring compliance quality and patient safety. We extend our heartfelt gratitude to the organizers for orchestrating such an insightful event!!
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CEO at Kamet Consulting Group | Life Sciences Strategy, Transformation, and Operations Leader | Pharmaceuticals | Medical Devices | Digital Health | Consumer Health | Food |
On May 6th, 2024, the US FDA finalized regulations for Laboratory Developed Tests (LDTs), amending the Federal Food, Drug, and Cosmetic Act (FDCA) to classify LDTs as medical devices. This classification subjects LDT manufacturers to several regulatory requirements, including premarket review, quality system regulations, adverse event reporting, and more. The FDA has also introduced a phased policy and timeline to transition existing LDTs to this new regulatory framework. For more detailed insights and guidance on navigating this transition, read further on our perspective, or contact us at?[email protected]?for a deeper discussion. Our team has extensive experience in assisting organizations with regulatory transitions.
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The FDA’s electronic Submission Template and Resource (eSTAR) is now available for voluntary use for 513(g) requests for information. This interactive PDF form guides applicants through the process of preparing a comprehensive medical device submission. Find out more:?https://lnkd.in/gwwGMwZS
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CEO at Kamet Consulting Group | Life Sciences Strategy, Transformation, and Operations Leader | Pharmaceuticals | Medical Devices | Digital Health | Consumer Health | Food |
We are still abuzz with excitement following our recent Global Regulatory Operations and Excellence Forum, which saw leaders from a diverse array of life sciences organizations in attendance. A heartfelt thank you goes out to our core team members, Scott Cleve, Susan Uptain, Ph.D., and Meghan Arthur, whose invaluable contributions helped shape the forum's agenda. We are also grateful to our partner Gens and Associates Inc. and Steve Gens MSOD for their collaboration and support. With participation from 17 leaders across 16 organizations, we delved into several pivotal topics affecting modern regulatory organizations, focusing particularly on strategies for navigating the influence of emerging technologies such as Gen AI to streamline and automate future processes. #RegulatoryOperations #GenAI #Automation #Pharmaceuticals #Lifesciences If you are interested in participating in our next forum, or having a discussion about any of these topics -- please reach out to [email protected] or you can directly message me on LinkedIn.