Our Services

End-to-end expertise across the product lifecycle.

From regulatory strategy and evidence development to market access and post-market safety β€” every service scoped to your asset, jurisdiction, and stage.

Regulatory Services

Regulatory Compliance

We help you build a global regulatory strategy backed by real evidence, so your product is ready for submission in any market.

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
Learn more about Regulatory Compliance

Field Operations

Medical Affairs & Medical Science Liaison (MSL) Services

We run your medical affairs and Medical Science Liaison (MSL) programs β€” from KOL engagement to scientific field operations.

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

Market Access

U.S. Market Entry

We turn your international device approval into a clear, step-by-step plan for entering the U.S. market through the FDA.

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

Talent & Training

MSL Recruitment & Training

We recruit, evaluate, train, and certify Medical Science Liaisons and scientific field staff tailored to your needs.

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

Research Services

Preclinical Research and Support

We design and manage preclinical studies β€” biocompatibility, toxicology, and lab testing β€” before you move to clinical trials.

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

Clinical Programs

Clinical Research

We plan and run clinical programs designed to meet regulatory requirements and support real-world adoption.

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

AI & Discovery

AI-Assisted Drug Discovery

We use AI tools to accelerate early-stage drug research β€” target identification, virtual screening, and lead optimization β€” all guided by expert scientists.

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

Commercial Strategy

Market Readiness

We prepare your product for a successful launch β€” from pricing and positioning to hospital targeting and field team planning.

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

ESG & Sustainability

Good ESG and Sustainability Strategy

We help you measure and improve your environmental, social, and governance performance with clear goals and reporting.

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

IP & Legal

IP Strategy and Due Diligence

We review your intellectual property portfolio to clarify ownership, assess competitive risk, and support licensing or acquisition decisions.

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

Safety & Surveillance

Post-Market Surveillance

We monitor safety signals, track adverse events, and manage regulatory escalations after your product reaches the market.

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

Ready to scope your next engagement?

Tell us about your asset, target market, and timeline. A Zebra BioSolutions specialist will respond within one business day.

Request Consultation