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Commercialization

The commercial phase is where your innovative drug or device transitions from development to market launch. Our team is dedicated to ensuring a successful entry into the marketplace.

Quality Management Systems (QMS) ​

Quality Assurance and Regulatory Compliance ​

Project & Risk Management ​

Gap Assessment and Remediation

FDA Inspection Readiness ​

Internal and Supplier Audits ​

Process Optimization ​

Vendor Selection & Qualification ​

Recruitment ​

Qualification and Validation ​

Computer System Validation (CSV) ​

GxP Training ​

Regulatory Strategy & Submissions ​

Strategic Advising ​

PreClinical

Clinical

Commercialization

All Services