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Formulation Development

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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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Featured Publication
Recent Options for Phase 1 Formulation Development and ClinicalTrial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology



Partners



 

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.






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:

Bioequivalence
Cardiac Safety
Dermatology
Labeling support studies


www.cetero.com/xcel


 

This team of former FDA review decision makers design, develop, report and integrate studies in all phases of development.

Preclinical Studies for Human and Veterinary Products
Non-clinical pharmacology, Toxicology, Toxicokinetics
Clinical Studies from First-in-Human to Phase IV
Power optimization and sample size determination
Statistical analysis of clinical-trial data
Interpretation of pharmacokinetics and pharmacodynamics
Chemistry, Manufacturing and Controls (CMC) for Drug Substance and Drug Product
Specification development and selection and evaluation of testing
Stability-study design including statistical analysis and matrixing
Drug Master File (DMF) preparation
Sterile-product manufacturing controls and testing
API supplier selection
Bioequivalence study design, analysis and reporting
Postmarketing Pharmacovigilance


www.xfda.com






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