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Latest Headlines
Xcelience and IriSys business alliance agreement strengthens regional access to CMC/Regulatory expertise
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| Xcelience Adds Piccola B10 Minipress for GMP Tablet Formulation Development in Experimental Area
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| Xcelience and Penn Pharma Form a Joint Venture to Provide API Into Capsule Services in Europe and Asia Pacific Markets
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Partners
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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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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
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www.cetero.com/xcel
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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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