Tangene Group LLC

Regulatory Services

• 510(k) and PMA Submissions for Medical Device
• Bioequivalence Study for Generic Drug
• 21 CFR 820 and ISO 13485 Implementation For Medical Device
• 21 CFR 210/211 Implementation For Drug and Pharmaceutical
• 21 CFR 111 Implementation for Herbal Supplement
• FDA 483 finding and warning letters remediation
• Interact with FDA, EU, JPAL, TGA etc.