Preclinical Support Services

Transcription

1 Preclinical Support Services Expert toxicology solutions providing consultation, study design testing and site monitoring to ensure a seamless transition of projects through IND-enabling studies and into clinical trials.

2 Study Design, Consultation and Monitoring Our Services NSF s expert toxicologists provide a complete package of consultation, study design Preclinical Study Design, Support and Monitoring and site monitoring services to ensure a seamless transition of your project through Complete design and support for IND-enabling study package Site auditing and monitoring analysis as needed, to provide a comprehensive report that is directly suitable for Formulation development and analysis regulatory submission. Toxicology and pharmacokinetic reporting The Right People. The Right Solution. The First Time. Clinical and Preclinical Bioanalysis NSF Health Sciences provides expert preclinical laboratory support, consulting and Method Development and Validation Plasma, blood, serum, synovial fluid, urine and feces Tissues the required IND-enabling studies and into clinical trials. Our services also include complete toxicological risk assessment, including DEREK training to the pharmaceutical, medical device and biotechnology industries. Our scientific, technical and project management staff is committed to supporting you through the product development cycle including bioanalytical methods development, validation and sample analysis. For more information about NSF Health Sciences and our preclinical services, please contact us at hstesting@nsf.org or call Liver, kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis Species - Non-human primate, rodent, canine, porcine, bovine and human Validation according to FDA guidance Sample Analysis Small and large molecules, oligonucleotides and aptamers Liquid-liquid extraction, solid phase extraction, protein precipitation, digestion UPLC/MS/MS, Waters UNIFI software Watson LIMS Bioanalytical Methods Development, Validation and Sample Analysis NSF provides bioanalytical methods development, validation and sample analysis in its FDA-GLP registered facility in Bristol, CT. We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. In addition to the traditional matrices of blood, plasma and urine, the NSF bioanalysis group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord, and vaginal tissue to name a few. Sample data is processed and reported using the Watson LIMS. All reports are delivered as ready to file documents. We also offer full API characterization as well as formulation concentration and stability analysis. In-Life Study Support NSF Health Sciences strategically partners with service providers to offer in-life studies in a variety of models. American Preclinical Services (APS), located in Coon Rapids, MN, performs ISO10993 and custom biocompatibility testing, interventional and surgical large animal research, toxicology, and pathology services. BioTox Sciences (BTS), located in San Diego, CA, provides GLP and non-glp toxicology studies including acute toxicity, subchronic toxicity, chronic toxicity, rangefinding studies, maximum tolerated dose, and safety pharmacology to investigate the effects of the test substance on vital functions including cardiovascular, respiratory, and central nervous systems.

3 Study Design, Consultation and Monitoring Our Services NSF s expert toxicologists provide a complete package of consultation, study design Preclinical Study Design, Support and Monitoring and site monitoring services to ensure a seamless transition of your project through Complete design and support for IND-enabling study package Site auditing and monitoring analysis as needed, to provide a comprehensive report that is directly suitable for Formulation development and analysis regulatory submission. Toxicology and pharmacokinetic reporting The Right People. The Right Solution. The First Time. Clinical and Preclinical Bioanalysis NSF Health Sciences provides expert preclinical laboratory support, consulting and Method Development and Validation Plasma, blood, serum, synovial fluid, urine and feces Tissues the required IND-enabling studies and into clinical trials. Our services also include complete toxicological risk assessment, including DEREK training to the pharmaceutical, medical device and biotechnology industries. Our scientific, technical and project management staff is committed to supporting you through the product development cycle including bioanalytical methods development, validation and sample analysis. For more information about NSF Health Sciences and our preclinical services, please contact us at hstesting@nsf.org or call Liver, kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis Species - Non-human primate, rodent, canine, porcine, bovine and human Validation according to FDA guidance Sample Analysis Small and large molecules, oligonucleotides and aptamers Liquid-liquid extraction, solid phase extraction, protein precipitation, digestion UPLC/MS/MS, Waters UNIFI software Watson LIMS Bioanalytical Methods Development, Validation and Sample Analysis NSF provides bioanalytical methods development, validation and sample analysis in its FDA-GLP registered facility in Bristol, CT. We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. In addition to the traditional matrices of blood, plasma and urine, the NSF bioanalysis group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord, and vaginal tissue to name a few. Sample data is processed and reported using the Watson LIMS. All reports are delivered as ready to file documents. We also offer full API characterization as well as formulation concentration and stability analysis. In-Life Study Support NSF Health Sciences strategically partners with service providers to offer in-life studies in a variety of models. American Preclinical Services (APS), located in Coon Rapids, MN, performs ISO10993 and custom biocompatibility testing, interventional and surgical large animal research, toxicology, and pathology services. BioTox Sciences (BTS), located in San Diego, CA, provides GLP and non-glp toxicology studies including acute toxicity, subchronic toxicity, chronic toxicity, rangefinding studies, maximum tolerated dose, and safety pharmacology to investigate the effects of the test substance on vital functions including cardiovascular, respiratory, and central nervous systems.

4 Study Design, Consultation and Monitoring Our Services NSF s expert toxicologists provide a complete package of consultation, study design Preclinical Study Design, Support and Monitoring and site monitoring services to ensure a seamless transition of your project through Complete design and support for IND-enabling study package Site auditing and monitoring analysis as needed, to provide a comprehensive report that is directly suitable for Formulation development and analysis regulatory submission. Toxicology and pharmacokinetic reporting The Right People. The Right Solution. The First Time. Clinical and Preclinical Bioanalysis NSF Health Sciences provides expert preclinical laboratory support, consulting and Method Development and Validation Plasma, blood, serum, synovial fluid, urine and feces Tissues the required IND-enabling studies and into clinical trials. Our services also include complete toxicological risk assessment, including DEREK training to the pharmaceutical, medical device and biotechnology industries. Our scientific, technical and project management staff is committed to supporting you through the product development cycle including bioanalytical methods development, validation and sample analysis. For more information about NSF Health Sciences and our preclinical services, please contact us at hstesting@nsf.org or call Liver, kidney, spleen, brain, spinal cord, heart, eye, muscle, dermis Species - Non-human primate, rodent, canine, porcine, bovine and human Validation according to FDA guidance Sample Analysis Small and large molecules, oligonucleotides and aptamers Liquid-liquid extraction, solid phase extraction, protein precipitation, digestion UPLC/MS/MS, Waters UNIFI software Watson LIMS Bioanalytical Methods Development, Validation and Sample Analysis NSF provides bioanalytical methods development, validation and sample analysis in its FDA-GLP registered facility in Bristol, CT. We support all types of preclinical studies from early discovery (ADME, PK, TK) through long-term chronic in all species. In addition to the traditional matrices of blood, plasma and urine, the NSF bioanalysis group has many years of methods development experience in complex matrices such as brain, spleen, spinal cord, and vaginal tissue to name a few. Sample data is processed and reported using the Watson LIMS. All reports are delivered as ready to file documents. We also offer full API characterization as well as formulation concentration and stability analysis. In-Life Study Support NSF Health Sciences strategically partners with service providers to offer in-life studies in a variety of models. American Preclinical Services (APS), located in Coon Rapids, MN, performs ISO10993 and custom biocompatibility testing, interventional and surgical large animal research, toxicology, and pathology services. BioTox Sciences (BTS), located in San Diego, CA, provides GLP and non-glp toxicology studies including acute toxicity, subchronic toxicity, chronic toxicity, rangefinding studies, maximum tolerated dose, and safety pharmacology to investigate the effects of the test substance on vital functions including cardiovascular, respiratory, and central nervous systems.

5 Our People James R. Scull, Ph.D. General Manager James Scull has more than 27 years of pharmaceutical development experience spanning all areas from discovery support through manufacturing. Dr. Scull s primary expertise is in the areas of applied analytical chemistry, toxicology and multi-dimensional separation science. He is also an expert in conducting extractable & leachable studies and oligonucleotide analysis. Kurt L. Moyer, Ph.D. Director of Research Kurt Moyer has more than 23 years of pharmaceutical development experience spanning all areas from discovery support to marketed products. His primary expertise is in the areas of bioanalysis, extractables and leachables, method development and validation, identification of impurities and metabolites, and GLP/ GMP compliance. He also has extensive experience with drugs for anticoagulant and cardiovascular therapies. Ulyana V. Matyugicheva, M.S. Group Leader, Bioanalysis Ulyana Matyugicheva has nearly 10 years of pharmaceutical development experience covering areas from early discovery studies to human clinical trials. Ms. Matyugicheva s primary focus is in analytical methods development in complex matrices, with an emphasis on novel extraction techniques. She also oversees development and implementation of new analytical technologies. John M. Mitchell, Ph.D. Consulting Toxicologist John Mitchell has over 20 years of experience in clinical study development and monitoring. With expertise in FDA, ICH, ISO, EMEA, Prop 65 and EPA guidelines, Dr. Mitchell provides safety evaluation and regulatory submissionadvice. He has conducted diligence of over 60 pharmaceuticals and medical device in-license opportunities.

6 Our Global Presence NSF Health Sciences Locations NORTH AMERICA > Ann Arbor, MI > Bristol, CT > Washington, DC EUROPE > Berlin, Germany > Sheffield, UK > York, UK LATIN AMERICA > Lima, Peru ASIA > Shanghai, China For more information about NSF Health Sciences preclinical support and testing services, contact call or visit LHS