5. BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Preclinical Phase I, II, III Phase IV
6. BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration We are experts in the development and validation of customised immuno, proteomic and cell-based methods for evaluation of: Biomarkers Biopharmaceuticals Biopharmaceutical related factors (anti-drug antibodies, neutralising antibodies, process and product related impurities etc.) Preclinical Phase I, II, III Phase IV
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8. BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Life Scientific can assist your biomarker and diagnostic requirements, be they focused on analysis of probable or known valid biomarkers, surrogate endpoints, fit-for-purpose analyses, analytical validation or clinical validation. Preclinical Phase I, II, III Phase IV
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10. BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Read Biomarkers in Drug Development in the February 2007 issue of Pharma Magazine http://www.nxtbook.com/dal/viamedia/pharmadigitalfeb2007/index.php Preclinical Phase I, II, III Phase IV
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13. BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Life Scientific provides regulatory affairs expertise on tap to help solve your registration and licensing issues. We offer a complete range of services, throughout Europe, from strategic consulting to maintenance support. Preclinical Phase I, II, III Phase IV
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16. Contacts Biopharmaceutical Division NovaUCD, Belfield Innovation Park, UCD, Dublin 4, Ireland Tel: +353 1 716 3511 Andy Roche [email_address]
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