Stability studies provide confirmation on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.
Prime role of the Stability studies is to enable identification of any potential chemical or physical changes that could theoretically impact product safety and quality
Umed stability studies (storage and testing) include:
Walk-in stability chambers of all different conditions
Stability studies (storage and testing) are performed as per ICH Q1A and photo stability testing as per ICH Q1B
We provider conditions like 25℃/60%RH; 30℃/65%RH; 30℃/75%RH; 40℃/75%RH; 2-8 ℃ and/or customer requirements
Stability protocol preparation, coordination with clients, well-timed pull out and analysis of stability samples.
Supporting to multiple clients for Storage at prescribe condition.
Real-Time Stability
Accelerated Stability
Photostability
Freeze-Thaw Study
Stability Studies performed on:
Active Pharmaceutical Ingredients (APIs) / Drug Substance
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.
