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Global Regulatory Intelligence

Move from international authorization to U.S. market entry.

Monitor official sources, preserve provenance, evaluate FDA pathways, and prioritize qualified medical-device opportunities.

Regulatory ServicesU.S. Market Entry

Global Regulatory Intelligence

6 jurisdictions

Official-source intelligence

Service 1 of 5

6Target jurisdictions
12+Integrated service lines
HumanReview at every critical decision
PrivateB2B intelligence by design

Integrated Capabilities

One operating partner across the product lifecycle.

Every engagement is scoped to the client, evidence base, jurisdiction, and stage of development.

Zebra BioSolutions capability

Regulatory Compliance

Evidence-led global strategy and submission readiness.

FDA classification and product-code assessment
510(k), De Novo, PMA and HDE planning
Q-Submission and labeling review
Quality-system and post-market readiness
Explore Regulatory Compliance

Zebra BioSolutions capability

Medical Affairs & Medical Science Liaison (MSL) Services

Scientific field operations separated from promotional activity.

Medical affairs and field medical strategy
KOL mapping and scientific exchange
MSL territory and deployment
Medical inquiry and insight management
Explore Medical Affairs & Medical Science Liaison (MSL) Services

Zebra BioSolutions capability

U.S. Market Entry

Translate international authorization into an actionable American pathway.

FDA match evidence review
Predicate and pathway analysis
U.S. agent and establishment planning
Market-entry gap assessment
Explore U.S. Market Entry

Zebra BioSolutions capability

MSL Recruitment & Training

Recruit, assess, train and certify scientific field talent.

Client recruitment requests
Scientist and MSL talent matching
Competency assessment and remediation
Client-specific certification programs
Explore MSL Recruitment & Training

Zebra BioSolutions capability

Preclinical Research and Support

Design the evidence package before clinical execution.

In vitro and in vivo study strategy
Biocompatibility and toxicology planning
CRO identification and qualification
Protocol, monitoring and data review
Explore Preclinical Research and Support

Zebra BioSolutions capability

Clinical Research

Clinical programs engineered around regulatory and adoption outcomes.

Feasibility, protocol and endpoint strategy
Investigator and site identification
Clinical operations and data review
Real-world evidence and PMCF
Explore Clinical Research

Zebra BioSolutions capability

AI-Assisted Drug Discovery

Computational prioritization governed by scientific review.

Target and biomarker discovery
Virtual screening and molecular docking
ADME and toxicity prediction
Lead optimization with human expert review
Explore AI-Assisted Drug Discovery

Zebra BioSolutions capability

Market Readiness

Prepare evidence, positioning and field execution for launch.

Competitive and customer segmentation
Reimbursement and pricing assessment
Hospital and physician targeting
Launch milestones and MSL planning
Explore Market Readiness

Zebra BioSolutions capability

Good ESG and Sustainability Strategy

Operational sustainability translated into measurable readiness.

ESG baseline and materiality
Carbon, waste, water and packaging strategy
Supply-chain sustainability
KPI, governance and reporting plans
Explore Good ESG and Sustainability Strategy

Zebra BioSolutions capability

IP Strategy and Due Diligence

Clarify ownership, differentiation and commercialization risk.

Patent landscape and portfolio review
Inventor, assignee and ownership analysis
Patent family and legal-status review
Licensing and M&A due diligence
Explore IP Strategy and Due Diligence

Zebra BioSolutions capability

Post-Market Surveillance

Human-reviewed safety intelligence, signal triage and regulatory escalation.

Recall and safety-notice monitoring
Adverse-event and complaint trend review
Corrective-action and escalation workflows
Client notifications with causality safeguards
Explore Post-Market Surveillance

Identify

Monitor official regulatory sources and preserve original evidence before normalization.

Qualify

Assess FDA pathway evidence, scientific gaps and market-readiness opportunities.

Execute

Convert qualified opportunities into secure, governed client projects and field programs.

Start with the evidence

Is your device ready for the U.S. market?

Request a confidential consultation with Zebra BioSolutions.

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