Our Projects & Case Studies

We proudly partner with leading biotech and pharmaceutical organizations to solve complex challenges with compliant and innovative solutions.

Comprehensive QA audit to ensure compliance with global GMP regulations for a leading biopharma company.

Developed a robust data management system to streamline clinical trial reporting and ensure data integrity.

Provided full regulatory support and documentation for a successful NDA submission, accelerating market entry.

Revised and standardized SOPs, BMRs, and compliance documents to align with FDA and EMA expectations.

Implemented a modern digital QMS for a pharma manufacturer, ensuring audit readiness and deviation tracking.

Conducted a complete safety and risk management review aligned with ICH E2E and global PV requirements.

Performed equipment IQ/OQ/PQ validation for a sterile injectable facility to ensure regulatory compliance.

Identified compliance gaps for international submissions and provided corrective action plans.

Assisted in preparing CTD modules and regulatory documentation for a successful Health Canada product filing.