Aexelar - Connecting Requlations & Science     
    
 

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Regulatory Affairs and Medical Information Experts


Aexelar Inc. is a consortium of pharmaceutical scientists with expertise in drug product development, registration & approval processes, and medical information & communication services.

Our experts have provided a broad range of services for several decades in areas of medical information and communication services, review of advertising and promotional materials, regulatory strategy development (clinical, non-clinical, and chemistry, manufacturing & controls - CMC), and development of global registration dossiers (NDAs, 505(B)(2)s, NDSs, MAAs). Our experts have supported over a dozen global drug product approvals in areas of medical information & services, regulatory strategy and dossier development, formulation and process development, scale-up and technology transfer, analytical methods development and validation, stability data evaluation and interpretation.

 
 
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