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We offer services in the following areas;
Pharmaceuticals, Biotechnology Products, Medical Devices, Diagnostics
Bioequivalence issues
Biostatistics
Clinical data
Clinical trials, conduct, management and monitoring
CRF design, tracking, & handling
Data management and QA
Drug chemistry, manufacturing and control
Drug Master File (DMF) preparation and maintenance
IND, IDE, NDA, ANDA, 510(k), and PMA, preparation and maintenance
Investigational and new drug submissions
Labeling and package insert issues
Nonclinical research & development
Protocol & CRF development
Remote data entry/monitoring
Veterinary drugs
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