Professional Consultant in Global Regulatory Affairs Management

Explore professional consulting services built to solve your global regulation compliance needs—from medical device, in-vitro diagnostics (IVD), pharmaceutical, biologics industries, and more…

RA One-Stop Solutions

Success-Link offers integrated, one-stop CRO solutions designed to navigate the entire product lifecycle through our “three-in-one” competitive advantage: Regulatory Affairs, Clinical Trials, and Supply Chain Quality Management

Integrated Regulatory Affairs

Gain focused insights and a clear action plan to move your business forward with confidence.

Global Regulatory Coverage

Clinical Trials

Supply Chain Quality Management

Regulatory Affairs & Global Market Access

We act as your gateway to international compliance, providing full-cycle support to ensure your products reach major global markets faster and more reliably.

Key Solutions

Global Regulatory Coverage

Strategy & Planning

Submission Management

Specialized Capabilities in Classification & Clinical Evaluations

Global Market Certifications

EU CE Marking

MDR (EU 2017/745)
IVDR (EU 2017/746)
Technical documentation compilation
Notified Body (NB) liaison

US FDA

510(k) Premarket Notification
PMA Premarket Approval
De Novo Classification Request
Q-Sub Pre-submission Consultation

China NMPA

Product registration
Classification determination
Clinical evaluation
Innovation/Priority review pathway

WHO Prequalification

End-to-end PQ guidance
Technical dossier preparation
Site inspection readiness
Accelerated review strategy

Asia-Pacific Markets

Japan PMDA
South Korea MFDS
Singapore HSA
Australia TGA
Philippines FDA

Americas

Canada Health Canada (MDL/MDEL)
Brazil ANVISA
Mexico COFEPRIS

Eurasia

Russia RZN / EAC certification
Kazakhstan
Belarus

Middle East

Saudi Arabia SFDA
UAE MOHAP
Israel AMAR

Other Emerging Markets

ASEAN (Vietnam, Indonesia, Thailand, Malaysia)
Africa
Latin America

Clinical Research Services

Success-Link helps manufacturers generate the high-quality, evidence-based data required for international regulatory approvals.

Key Solutions

End-to-End Management

Compliance Standards

High-Risk Expertise Portfolio Experience

Clinical Trial Design

Protocol development
Statistical analysis plan (SAP)
Endpoint selection
Sample size calculation

Clinical Evaluation

Clinical Evaluation Report (CER) per MDR Annex XIV
Literature review
State-of-the-art (SOTA) analysis

Trial Management

Site selection & initiation
Monitoring
Data management
Safety reporting

Biostatistics

Statistical programming
Interim analysis
Final study report (FSR)

Regulatory Clinical Strategy

FDA IDE / IND
NMPA clinical trial approval
Clinical data for 510(k) / PMA / MDR / WHO PQ

Post-Market Clinical Follow-up (PMCF)

MDR PMCF plan & report
Real-world evidence (RWE) generation

Supply Chain Quality Assurance on Your Behalf

We manage your vendor network proactively conducting qualification audits, monitoring production quality, andensuring regulatory complianceto eliminate supply chainrisks at the source.

Key Solutions

On-Site Supplier Audits

Multiple Product Inspection Modes

Global Reporting with Timely Efficiency

Quality System (QMS) Consulting

Building a strong foundation of compliance is essential for long-term success. We provide specialized coaching to ensure your systems are regulation-ready.

Key Solutions

Gap Analysis

Full Audit System Establishment

Mock Audits

ISO 13485

System implementation
Gap analysis
Internal auditor training
Certification support

GMP Compliance

China GMP
EU GMP
FDA cGMP gap remediation

MDSAP

Five-country unified audit program (FDA / Health Canada / TGA / PMDA / ANVISA) preparation & guidance

Inspection Readiness

Unannounced inspection response
Mock inspections
CAPA development
Regulatory authority communication support

QMS Integration

Multi-market system integration (NMPA + ISO 13485 + MDR + MDSAP unified framework)

Comprehensive Regulatory Affairs Solutions.

Get your product in compliance for rapid global market access. Covering medical devices, in-vitro diagnostics, pharmaceuticals, and biologics.

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