What We Can Do for You
Protocol Design Expertise
We provide meticulous protocol design to ensure robust, scientifically sound clinical trials and bioequivalence studies.
CRO Coordination
Our team efficiently organizes and manages Contract Research Organizations (CROs) to ensure seamless clinical trial execution.
IVIVC & IVIVR Studies
We conduct In Vitro-In Vivo Correlation (IVIVC) and In Vitro-In Vivo Relationship (IVIVR) studies to optimize drug formulations and predict clinical performance.
BE/CT Failure Investigation & Reformulation
Our experts analyze bioequivalence and clinical trial failures, offering reformulation strategies to ensure regulatory approval.
BCS Waiver
We assist with Biopharmaceutics Classification System (BCS) waiver applications, streamlining regulatory processes and reducing clinical trial requirements.
Impurity Qualification
Our services include comprehensive impurity qualification, ensuring safety and compliance with regulatory standards.
Genotoxicity Evaluation
We offer thorough genotoxicity evaluations to assess potential risks, ensuring product safety and regulatory adherence.