BENAR Consulting Inc. Provides Global Regulatory Support for New Product Development & Life-Cycle Management

OUR SERVICES

Medical Device Class I, II, III Global Regulation

Global Regulatory Strategy

510(k) / De Novo / Presub / SIR

Technical File / Design Dossier / MDD / MDR

Audits/ QRB / Issue Escalation/ CAPA

International Regulatory Registration

Regulatory Due Diligence & Merger

FDA / Notified Body Relationship Management

Regulatory Operation and Intelligence

Labeling, Advertisement & Promotional Material

Regulatory Affairs Process Excellence

Combination Product Regulatory Strategy and Submission

Pharmaceutical CMC Contents

US Cosmetic Regulation