Our Services

Comprehensive analytical chemistry and quality control solutions for biotech companies developing small molecules

Analytical Method Development & Validation

Comprehensive method development and validation services following ICH guidelines to ensure robust, reliable analytical procedures for your small molecule compounds.

GMP Laboratory Setup and Compliance Review

Complete laboratory setup guidance and compliance reviews to ensure your facility meets current Good Manufacturing Practice standards.

Wide Range of cGMP Documentation Review

Thorough review of cGMP documentation, including deviations, batch operating procedures, in-process data, and release data, to ensure compliance and accuracy.

Out-of-Spec (OOS) Investigation Guidance, Root Cause Analysis & CAPA Generation

Structured approach to OOS investigations, including expert root cause analysis and effective CAPA (Corrective Action, Preventive Action) generation to maintain product quality and regulatory compliance.

Stability Study Design and Oversight

Design and oversight of stability studies according to ICH guidelines to support shelf-life determination and storage condition recommendations.

Analytical Data Review & Audit Prep

Thorough review of analytical data and preparation for regulatory audits to ensure data integrity and compliance with industry standards.