Drug Development Consulting
Your Vision.
Our Innovation.
Bringing your vision to life through strategic insights, optimized processes, and our collaborative approach.
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Focused on meeting the unique needs of our multinational biopharmaceutical clients, our highly experienced team specializes in process optimization to ensure successful regulatory inspections and drug approvals.
A BROAD RANGE OF EXPERTISE ACROSS A FULL SPECTRUM OF REGULATORY SITUATIONAL AREAS.
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
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
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
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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Join Our Global Team
RegDev is comprised of seasoned, diverse, professionals who collaborate to bring the best life science therapies to life. This takes an open and transparent culture that few other industries achieve. Learn more about the culture and opportunities awaiting you at RegDev.
