Provides expert in global regulatory compliance.

Specialize in quality system development and remediation.

Provide strategic regulatory planning, submission preparation and review.

We offer process, sterilization validation, equipment and cleanroom qualification.

Develop Clinical Quality Management Systems, conduct GCP and clinical site audits.

FDA regulatory compliance training, including submission requirements.

Offer statistical analysis planning, data processing, clinical trial randomization, and methodology consulting.

Conduct mergers and acquisitions, assess regulatory compliance risks, and conduct post-acquisition compliance.

We offer comprehensive logistics and distribution services, regulatory strategy, licensed brokerage support