• Quality Documentation Generation
• Equipment Validation
• Validations for NDA and PMA
• Auditing for GMP, GLP
• Automation Development
• Automated Pipetting and Incubation Robotics
• In Vitro Diagnostic (IVD) Scriptwriting
• IVD Validations
• Security Testing for Part11 Compliance (Electronic Records & Electronic Signatures, required by all 3 branched of the FDA)
• IQ, OQ, PQ Process Validations
• Validate equipment to IST and other specifications

• Pharmaceutical
• Medical Device
• Biologic

With offices in Boston and Indiana, we have more than 20 years of experience, and clients all over the world.

For more information, please email us.