Global Medical Device & Pharmaceutical Product Registration

Global Regulatory Service Bureau for Medical Device & Related Companies

Top Roast Consulting is a one-stop-shop to help overcome the challenges that arise in an environment of ever-evolving global regulations, increased globalization and redefined stakeholders. We offer a broad spectrum of regulatory submission and consulting services to support your business, customized to meet your specific needs.

Submission Component Preparation
· Initial strategic assessments of regulatory options and pathways
· Scanning services and legacy document conversion
· Preparation of Technical Files
· English to Chinese Translation

Global Registration & Submission
· Regional regulatory consultation in Asian Pacific Area
· Obtaining a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG) and Embassy Stamp
· CCC Certificate Registration in China
· Technical support for design and development including: Risk assessments, Product and materials testing,

Biocompatibility, Sterility validation, Software validation
· Physical Local Document Submission
- local in-country representation
- distributor qualification and clinical trials

Quality
- Quality system compliance

Training and Education
· Introduction to Regulatory Strategy and challenge of local medical device regulations
· Submission and document lifecycle processes and concepts
· Considerations for product classification and registration

Status: 

Operating

Industries: 

Employee Count Range: 

11-50

Company type: 

Privately Held

Founded year: 

1998

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