Biological Evaluation Plan

Comprehensive toxicological risk assessments and regulatory consulting for medical device and pharmaceutical safety. Delivers ISO 10993, REACH, and ICH M7 compliance documentation using QSAR and read-across analysis to support global regulatory submissions. Provides animal-free in-silico data and OEL/OEB reports for active pharmaceutical ingredients and device materials.

Medical device evaluation services providing systematic assessment, regulatory compliance review, and clinical validation support for medical devices and IVDs. Services include safety and efficacy evaluation, standards compliance verification, and documentation support to facilitate market entry and regulatory approval.

Medical device safety evaluation services for regulatory compliance and risk assessment. Provides comprehensive testing, biocompatibility analysis, and standards compliance documentation to support market approval and device certification across global markets.