Palamur Biosciences Private Limited is a full service preclinical contract research organization operating at sub urban of Hyderabad city, Mahabubnagar close to Hyderabad international airport, Telangana State, India. Palamur is established in the year 2008 as a centre of excellence for undertaking GLP toxicology / safety assessments, exploratory and basic research studies. Palamur is promoted by key trustees of SVS Educational Society which manages the SVS Medical, Dental, Nursing and Lab technology institutes. Palamur facility is the only facility approved by Govt. of India for commercial breeding and trading of Beagle Dogs in India.
A Marketing Authorization Application (MAA) for a new pharmaceutical / Chemical must contain all preclinical data available on the product specification and quality, bioavailability (applicable only drugs) and metabolism, toxicology and safety pharmacology as well as efficacy and pharmacodynamics. This information must be provided to the regulatory authorities before initiation of clinical testing in humans.
Guidelines followed Our studies are in full accordance to the applicable international guidelines and directives from the Schedule Y, CIB-RC, EMA, OECD, EU, ISO, FDA or EPA. We perform studies required for the approval of your drug with the regulatory authorities as well as studies on your chemical for its registration with the European Chemicals Agency ECHA for the REACH program. We´ll also test your food additive according to the European Food Safety Authority EFSA.
Palamur Bioscience scientific team members are highly experienced in both field of specialization and quality systems like GLP / NABL. All the studies are executed by GLP trained scientific personnel with an aggregate experience of close to 100 years of expertise in study design and execution. Animal technicians and handlers are trained as per FELASA and approved SOPs.your drug with the regulatory authorities as well as studies on your chemical for its registration with the European Chemicals Agency ECHA for the REACH program. We´ll also test your food additive according to the European Food Safety Authority EFSA.
Palamur Bioscience is registered with the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) as a Ministry of Environment & Forests; Govt. of India approved Animal Testing / Breeding / Trading Facilities (Rodents / Non-Rodent (Beagle Dogs) and operates in compliance with CPCSEA Guidelines.
Palamur Bioscience is accredited by AAALAC (Assessment and Accreditation of Laboratory Animal Care). The AAALAC International accreditation program evaluates organizations that use animals in research, teaching or testing. Those that meet or exceed AAALAC standards are awarded accreditation.
Palamur Bioscience is approved and issued the certificate by the National GLP Compliance Monitoring Authority (NGCMA), a statutory body constituted by the Government of India, after successfully clearing preliminary and final audits.
The certification covers the areas of Acute toxicology, Sub acute, Sub chronic, genotoxicology, Analytical Chemistry and Ecotoxicology studies. NGCMAI administers the GLP program in India as a full member state and participant in the principles of GLP charter of the Organization for Economic Cooperation and Development (OECD). As a result, data generated at Palamur Bioscience is now recognized by member countries around the world, including: Canada, Germany, Japan, and the U.S. The experiment species covers both rodents & non rodents.
Palamur Biosciences is certified by National Accreditation Board of Laboratory to medical device testing’s under the scope of Biological Testing. NABL is the accreditation body which operating under the ministry of Science and Technology, Govt. Of India.
Palamur Biosciences also recognized by Department of Scientific and Industrial Research to undertake R&D activities. DSIR is operating under the ministry of science and technology, Govt. Of India.