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Latest Headlines
Four contractors team for drug development
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| Xcelience Expands Xcelodose® Services To Enable Preliminary Compound Evaluation In The Experimental Area
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| 52 Perspectives: “Key Success Factors in Contract Manufacturing Small-Molecule Drugs”
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Partners
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Today’s Research for Tomorrow’s Healthcare
Our name is new. Our reputation is not. PRACS Institute, Gateway Medical Research and Ba Research International are proud to announce that they have joined together to become Cetero Research.
Cetero Research specializes in early clinical research and bioanalysis. Since we are specialists our systems have been refined and optimized for maximum accuracy, efficiency and timeliness.
Cetero Research provides your pharmaceutical companies with practical, focused and affordable solutions for:
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Bioequivalence |
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Cardiac Safety |
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Dermatology |
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Labeling support studies |
www.cetero.com/xcel
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ScienceDocs
ScienceDocs is the definitive source for comprehensive scientific
and medical research support. Services include statistical programming, study design
consultation, scientific editing and language translation for technical documents.
www.sciencedocs.com
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This team of former FDA review decision makers design, develop, report and integrate
studies in all phases of development.
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Preclinical Studies for Human and Veterinary Products
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Non-clinical pharmacology, Toxicology, Toxicokinetics
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Clinical Studies from First-in-Human to Phase IV
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Power optimization and sample size determination
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Statistical analysis of clinical-trial data
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Interpretation of pharmacokinetics and pharmacodynamics
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Chemistry, Manufacturing and Controls (CMC) for Drug Substance and Drug Product
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Specification development and selection and evaluation of testing
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Stability-study design including statistical analysis and matrixing
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Drug Master File (DMF) preparation
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Sterile-product manufacturing controls and testing
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API supplier selection
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Bioequivalence study design, analysis and reporting
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Postmarketing Pharmacovigilance
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www.xfda.com
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Cambridge Major Laboratories, Inc. is a leading global service-based chemistry outsourcing partner to the pharmaceutical and biotechnology industries. The Company produces pharmaceutical intermediates and Active Pharmaceutical Ingredients, from early preclinical development to post-NDA approved commercial products. Operating from four facilities in the US and Europe , the Company has been FDA inspected and approved for cGMP manufacturing.
Visit us at www.c-mlabs.com.
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