About Us

Rapidly evolving biomedical development regulations represent a complex environment in which to develop and commercialize new therapeutics. To assist you in addressing these challenges, GloboScience has assembled an exceptional team of international regulatory, scientific, clinical, medical and biostatistics experts.

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Experience

GloboScience’s experience as Drug Regulatory Authorities (DRAs) supervisors, reviewers, and industry strategists has forged a unique comprehension of the product-specific complexities and benefit-risk methodologies applicable to pharmaceutical, biologics, medical device, consumer health and new product development.

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Expertise

Whether you have a product in preclinical or clinical development, GloboScience implements an experience-based approach to provide strategic, scientific and regulatory services that results in first cycles approvals and regulatory successes for our clients globally. Our approach allows us to focus and streamline our clients’ development efforts, reducing developmental time and costs.

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Services

Whether you have a product in preclinical or clinical development, GloboScience implements an experience-based approach to provide strategic, scientific and regulatory services that results in first cycles approvals and regulatory successes for our clients globally. Our approach allows us to focus and streamline our clients’ development efforts, reducing developmental time and costs.

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Projects

Whether you have a product in preclinical or clinical development, GloboScience implements an experience-based approach to provide strategic, scientific and regulatory services that results in first cycles approvals and regulatory successes for our clients globally. Our approach allows us to focus and streamline our clients’ development efforts, reducing developmental time and costs.

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Join Us

Whether you have a product in preclinical or clinical development, GloboScience implements an experience-based approach to provide strategic, scientific and regulatory services that results in first cycles approvals and regulatory successes for our clients globally. Our approach allows us to focus and streamline our clients’ development efforts, reducing developmental time and costs.

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global scientific & regulatory consulting for foods, drugs, devices, cosmetics and chemicals

Product Expertise

Learn more about GloboScience’s product expertise.

Therapeutic Expertise

Learn more about GloboScience’s therapeutic expertise.

Sector Expertise

Learn more about GloboScience’s sector expertise.

Country Expertise

Learn more about GloboScience’s country expertise.

Regulatory Consulting

Scientific Consulting

Regulatory Strategy

Strategic Planning

Regulatory Submissions

CMC & Manufacturing

Advertising & Promotion/ Labeling

Clinical Regulatory

Nonclinical Regulatory

What is Regulatory Science?

Dr. Margaret Hamburg,U.S. FDA Commissioner (May ’09 – April ’15)

Regulatory Science @ FDA

Dr. Carolyn Wilson, Assoc. Director for Research, CBER, FDA

What's RS Got to Do @FDA

Frank Weichold, MD, PhD, Director, Critical Path and RegSci Initiatives, ORSI, FDA

Regulatory Science in 2016: Highlights

May 7th & 18th May 2016 NIBSC’s 40th anniversary Symposium