Regulatory Service

MEDICAL DEVICE & IVD REGISTRATION

• General medical device; IVD; medical devicedrug interphase
• Device Classification
• Technical File Preparation, CSDT
• Technical Document Submission
• Post-market surveillance

PHARMACEUTICAL & COSMETIC REGISTRATION

• New Drug Products, biologics; generics, health supplements; natural products; medical device-drug interphase; OTC; cosmetic
• Strategic Regulatory Consulting
• Dossier management
• Regulatory Submissions
• Pharmacovigilance