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CRITICAL BUSINESS SOLUTIONS

We Ensure You Meet the Challenges of Complex Regulatory Requirements

We critically review all processes from application strategy through product approval and provide solutions that guide clients through successful clinical trial executions, regulatory approvals, and inspections.

Strategic Drug Development

Strategic Drug Development

Navigating the Drug Approval Process

Strategic Drug Development services address all your clinical trial and drug development needs. In compliance with ICH guidance and CFR regulations, we guide you through preclinical to phase I - III trials, enabling drug approval.

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Independent Verification

Independent Verification

OBJECTIVE EVALUATION. EVIDENCE-BASED CONFIRMATION.

Independent Verification is the evidence-based process of evaluating and confirming, by an independent qualified person, that a given operational process or system is conducted in accordance with associated regulatory expectations.

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Risk Management

Risk Management

IDENTIFY, ASSESS, AND CONTROL CHALLENGES

An effective risk management program allows an organization to evaluate the full range of risks, assesses the relationship between different types of risk, and examines the impact they could have on various business goals.

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Quality Management Systems

Quality Management Systems

Ensure Quality, Safety, Performance, and Compliance

Quality Management System (QMS) is a set of formalized processes, records, policies, and procedures designed to ensure quality is built into products, products are safe and perform as intended, and products meet regulatory standards.

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