With international expertise, our team offers a range of quality services from QP release, EU/EEA importation, to complaint management, qualification and validation.
We provide product-specific quality management and development for a wide variety of medicinal products and medical devices throughout a product’s entire lifecycle, and have experience in regulatory compliance, vendor management and GxP audits.
Global Regulatory Inspections*
US FDA, KOREAN FDA, NDA, UK MHRA, Japanese PMDA, Italian AIFA, Brazilian ANVISA, GGC Including, ISO14001, ISO9001
Human, veterinary and controlled drugs
*Contact us for specific site regulatory authority approvals
Our proactive approach tracks changes in the regulatory environment, enabling us to provide our customers with guidance and quality strategies to ensure all requirements are met.