Global Scientific & Regulatory Affairs

Unlock Regulatory Success with Avance Clinical’s Global Scientific and Regulatory Affairs Department

At Avance Clinical, we understand the challenges faced by biotech companies in navigating the complex landscape of scientific and regulatory affairs. That’s why our Global Scientific and Regulatory Affairs Department is committed to providing comprehensive solutions tailored to meet the unique needs of our clients.

Our mission

Our mission is to connect biotech companies with the right preclinical choices through our ClinicReady services and guide them through the global clinical development continuum with our GlobalReady solutions. We act as a surrogate development department for start-up companies, assisting them in demonstrating safety and preliminary clinical proof of concept of their assets.

AVANCE CLINICAL
Our mission

Expertise

We boast deep scientific and regulatory experience and knowledge, allowing us to provide unparalleled guidance to our clients.

Collaboration

We work closely with our clients to understand their needs and tailor our services to help them achieve their milestones efficiently.

Compliance

We ensure rigor, compliance, and efficiency across all stages of drug development, trial delivery, and registration planning.

Services
We Offer

Regulatory Strategy Development

We devise regulatory strategies to navigate diverse regulatory landscapes, ensuring timely submissions and approvals.

Liaison with Regulatory Authorities

We serve as the primary liaison between our clients and regulatory authorities, maintaining open lines of communication and addressing inquiries promptly.

Surrogate Development

Acting as a surrogate development department, we assist start-up companies in demonstrating safety and preliminary clinical proof of concept of their assets.

Streamlined Marketing Application

Our medium-term aim is to offer a streamlined and flexible marketing application experience to our clients through our fully integrated functions within SRMA, harnessing our comprehensive global expertise.

Adherence to GCP Standards

Clinical Practice (GCP) standards, safeguarding the integrity and ethical conduct of clinical trials.

SCIENTIFIC & REGULATORY AFFAIRS TEAM

Solution-oriented team of regulatory experts, fostering a strong culture of compliance and customer-centricity.

Gabriel Kremmidiotis

Gabriel Kremmidiotis

Chief Scientific Officer

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Kevin Leach

Kevin Leach

Senior Vice President, Scientific and Regulatory Affairs

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Jorgen Mould

Jorgen Mould

Senior Vice President, Global Scientific & Regulatory Affairs

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Kate Bush

Kate Bush

Senior Director, Medical Writing Services

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Pilar Garzon

Pilar Garzon

Senior Director, Safety and Medical Monitoring Services

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Robert (Bob) Ezzell

Robert (Bob) Ezzell

Director of Regulatory Operations

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Thomas (Tom) Avery

Thomas (Tom) Avery

Associate Director of Regulatory Operations

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Annie Roten

Annie Roten

Associate Director, Strategic Site Solutions

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Dalal Murgai

Dalal Murgai

Senior Vice President, Global Regulatory Affairs

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Contact Us

Ready to streamline your regulatory affairs and ensure compliance with international regulations? Contact Avance Clinical below. Meet our expert team here. Trust Avance Clinical to be your CRO partner in biotech regulatory success.

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