Pharmaceuticals

We provide clients in the pharmaceutical industries with toxicology and product safety assessment guidance during preclinical testing phase. We work with clients in the evaluation and interpretation of the safety of existing and potential products, metabolites, degradants impurities and intermediates. We review license candidates and perform due diligence audits as well. We have helped a lot of generics manufacturers deal with the issues of impurities.

We design study specific protocols, initiate, monitor and report GLP and screening preclinical studies. We can also place studies with a reliable worldwide network of contract research organizations. Vast experience is utilized in monitoring preclinical animal studies, including general toxicology (acute to repeated dose), carcinogenicity, reproductive toxicology, teratology, in vitro and in vivo genetic toxicology and safety pharmacology. Services are also available for auditing and reviewing studies conducted internally or at outside laboratories. We prepare all toxicology components for regulatory submissions.

We also perform GLP audits of preclinical studies, facility audits, and GLP training for employees and trainers . These may be conducted at an internal laboratory, a university or at a Contract Research Organization (CRO) worldwide. Quality assurance audits and reports are issued at the conclusion of these audits. Suggestions are also offered for issues that arise during these GLP inspections and audits.

  • Preclinical strategy recommendations
  • Toxicology program design
  • Clinical Research Organization (CRO) selection
  • Contract management
  • Project management
  • Study protocol development and review
  • Study monitoring on behalf of clients
  • Report review and expert opinions
  • Dossier for regulatory submission

Some of our peer reviewed publications in this area

  1. 1.Kumaravel TS, Vilhar B, Faux SP, Jha AN. Comet Assay measurements: a perspective. DOI: 10.1007/s10565-007-9043-9 Cell Biol Toxicology 2007.
  2. 2.Burlinson B, Tice RR, Speit G, Agurell E, Brendler-Schwaab SY, Collins AR, Escobar P, Honma M, Kumaravel TS, Nakajima M, Sasaki YF, Thybaud V, Uno Y, Vasquez M, Hartmann A. Fourth International Workgroup on Genotoxicity testing: Results of the in vivo Comet assay workgroup. Mutat Res. 2007 Feb 3;627(1):31-5.
  3. 3.Kumaravel T.S, Bristow R. G. Detection of genetic instability at Her-2 and p53 loci in breast cancer cells using Comet-FISH, Breast Cancer Research and Treatment, 91(1):89-93, 2005.Fan R, Kumaravel T.S, Jalali F, Marrano P, Squire J.A, Bristow R.G. Defective DNA strand Break repair in prostate cancer cells: Implications for genetic instability and prostate carcinogenesis. Cancer Research, 64(23):8526-33, 2004.
  4. 4.Fan R, Kumaravel T.S, Jalali F, Marrano P, Squire J.A, Bristow R.G. Defective DNA strand Break repair in prostate cancer cells: Implications for genetic instability and prostate carcinogenesis. Cancer Research, 64(23):8526-33, 2004.
  5. 5.Inna I. Kruman, T. S. Kumaravel, Althaf Lohani, Ward A. Pedersen, Roy G. Cutler, Yuri Kruman, Norman Haughey, Jaewon Lee, Michele Evans, and Mark P. Mattson. Methyl donor deficiency impairs DNA repair and sensitizes hippocampal neurons to death in experimental models of Alzheimer's disease. Journal of Neuroscience, 2002 March 1, 2002, 22(5):1752-1762.
  6. 6.Li N.J, Gorospe M, Chrest J, Kumaravel T.S, Evans M.K, Han W.F, Pizer E.S. Pharmacological inhibition of fatty acid synthesis activity is cytostatic for cells with wild type p53 and cytotoxic for p53 deficient cells. Cancer Research 61: (4) 1493-1499 FEB 15 2001.
  7. 7.Arrington E.d, Cadwell M.C, Kumaravel T.S, Lohnai A, Joshi A, Evans M.K, Chen H, Nissenweig A, Holbrook N.J, Gorospe M. Enhanced sensitivity and long term G2 arrest in hydrogen peroxide-treated Ku80-null cells are unrelated to DNA repair defects. Free Radical Biology & Medicine. Vol 29 (11), 2000, 1166-1176.

OUR FOCUS



TESTING

  • High Quality, Cost Effective Testing
  • General, Genetic, in-vitro and Eco-toxicology
  • Mechanistic and Investigative Toxicology

CONSULTATIONS

  • Scientific and Regulatory Affairs
  • 3rd Party Study Monitoring


WHY GLR?


  • High Quality Standards
  • Cost Effectiveness
  • Regulatory and Scientific Consultations


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