Container closure systems are the elementary source for Leachable materials might arise from pharmaceutical route equipment, medical device packaging, and migrate to contaminate yields. Extractable and Leachable (E/L) studies to identify and quantify these complexes, ensuring the quality and effectiveness of the drug product.
Selection of container closure system (CCS) for dosage forms and medical devices
Design, develop and execute the E&L study for pharmaceutical industry according to the various regulatory guidelines and recommendations such as USFDA (USP <1663> and <1664> General Chapters), ICH and/or customer requirements.
Techniques used are GC-MS/MS, HS-GC-MS, LCMS, ICPMS; sox let extraction apparatus and others for samples processing.
A full-service extractable and leachable testing program also helps you to fulfill the regulatory requirements
The E/L studies is performed on Containers closure systems made up of (HDPE, LDPE, PP), Plastic bags, Rubber stoppers, Gaskets & O-rings, Glass vials, Prefilled syringes, Syringes, Injectable bags / vials, Laminated tubes, Tubing & filters and etc.,
Crucial Containers, Secondary Articles and Manufacturing Aids used for various drug products such as Solids, Parentals, Injectables, Ointments, Syrups, Suspensions, Gels, Creams & Emulsion, etc.,
Dr. UV Reddy is the founder and chairman of UMED LABS. Leading Umed since 2011, he brings with him over 12 years of experience in various roles in the pharmaceutical industry. Under his leadership, company significantly transformed from a small-sized domestic operation into a global independent product testing company.
With his wealth of knowledge Dr. UV Reddy established Contract Testing and Clinical Diagnostics Lab in the year of 2021 at Medical Device Park Hyderabad.
Dr. UV Reddy founded the Revive Pharma (OSD Facility) at Uganda in the year of 2021.
Dr. UV Reddy believes in sustainable and innovative business practices. Towards this, he is engaged with strengthening the company capabilities.
U.VASUNDRADEVI
MD & Co-Founder
Mrs. U.Vasundharadevi has been the Managing Director and Co-Founder of UMED since 2011. She has fifteen years of expertise in functional and management activities. She has also served as a financial advisor in addition to her other roles at UMED
P.SUBBA REDDY
Vice President
Mr. P. Subba Reddy is a Master of Science (Organic Chemistry) graduate. He is serving as a vice president of global marketing and analytical operations since 2018 in UMED. Prior to this, worked for more than 20 years in the API/Formulations sector, including R&D, new product development, manufacturing, troubleshooting, and customer concerns, at Dr. Reddy's & Granules India Ltd. His areas of strength are marketing, manufacturing, and research. He has published and received more than 65 patents.
R.RAMESH RAO
Technical Quality Control
Mr. Ramesh Rao is a Technical Consultant in UMED. He had a Rich experience and expertise in Analytical Method Development, Method Validation and Preformulation (Drug substance, Drug Product and Excipients). He had Very Good Expertise Trouble Shooting and providing Regulatory Compliance (analytical queries).
Prior to this, He had Started His Carrier from 1986 on wards, During his Carrier, He worked in varies MNC companies like Alembic, Zydus, Torrent, Unimak Remedy’s Emmure, Amneal and Aurobindo pharma, Mr. Ramesh had strong leadership quality and he handled more than 200Scientists During His Carrier
S.K.M VALI
GM Quality Head
S.K.M VALI is Master of Science graduate, serving as General Manager in Quality since 2019. Prior to this he worked with various domains AR&D, Quality control and Quality Assurance departments. He has extensive experience with analytical investigations and has been the subject of numerous regulatory and client audits at MNC’s and domestic companies.
DR.V.THARANATH
General Manager
Dr.V.Tharanath is Head of the Biologics Department . He joined UMED in 2023.He is having Ph.D. in VIROLOGY as his qualification &10yrs of opulent industrial experience including vaccine industry. He owned two prestigious fellowships, one is 'Meritorious student' award from Govt. of India and another is 'ERASMUS MUNDUS BRAVE' fellowship from European Union. After he joined UMED in 2023, become elevated front runner of the department. Giving his extensive knowledge in pharma contract research and testing industry. He is having huge bottomless area awareness in Biopharmaceutical studies.
MANIVARDHAN.REDDY
Operations Head Unit-I
Mr. M.V. Reddy is a Master of Science graduate, serving as Operations Head(Unit-1) since 2014. Prior to this he worked in various domains such as injectable & OSD plant setups in domestic & multinational pharma/Biotech industries. He has extensive experience Risk Assessments & Mitigation plans for new facility setup.
