Contract Research & Manufacturing

Methods Development and Analytical Testing Services

High Quality Results with Rapid Turn Around

Saladax Biomedical is a diagnostics company with over 20 years experience providing a broad range of diagnostic development services to the pharmaceutical and diagnostic industries. Founded by former Roche Diagnostic executives in 2004, Saladax is dedicated to delivering high quality work, fast results, and cost-effective solutions for its partners. Saladax works with leading pharmaceutical and biotech companies to provide a variety of diagnostic development services including:

• Developing bio-analytical assays for clinical trials and research use
• Analytical testing services for routine and specialty analytes
• Methods development, validation, and testing for clinical trials and for companion diagnostic development
• Assays for small molecule and protein markers
• Immunological and nucleic acid-based technologies
• GLP assay development for biomarkers used in clinical trials
• Preparing IND applications for FDA reviews
• A wide range of clinical indication areas

Saladax conducts all research in a GMP environment, with GLP elements required for sample testing, out of its state-of-the-art laboratory fitted with best-in-class instrument platforms and research equipment and housed within its headquarters in Bethlehem, PA.

Expertise:

• ISO 13485 certified facility
• cGMP and GLP Laboratories
• Production of CE marked in vitro diagnostic assays
• FDA approved tests
• Extensive list of pharmaceutical and diagnostic clients