Manufacturing Excellence. Compliance Assured.

Bridge the gap between technical operations and regulatory requirements. We ensure your CMC strategy is robust, compliant, and ready for scrutiny.

Refuse to File (RTF)

100%

Audit Success

Global

GMP Standards

Quality by Design

Key Deliverables

Comprehensive support tailored to your specific regulatory needs.

Comprehensive writing and critical review of CTD Module 3 (Quality) to ensure your manufacturing data supports approval.

Mock inspections and gap analyses to ensure your manufacturing facilities and quality systems are inspection-ready.

Validation and documentation support for electronic records and signatures to meet strict FDA digital compliance standards.

Design and analysis of stability protocols to support shelf-life claims and storage conditions.

Strategic guidance on qualifying impurities and degradants to meet ICH guidelines and ensure patient safety.

A proven methodology designed to minimize risk and maximize speed to market.

We review your current CMC data and quality systems against current regulatory standards to identify critical vulnerabilities.

We develop a prioritized action plan to address gaps, balancing compliance risks with business timelines.

Our experts work alongside your technical teams to generate data, write reports, and implement quality controls.

We compile and polish your CMC dossier, ensuring a cohesive narrative that justifies your control strategy to regulators.