4,000+

Health Authority Meetings

2,000+

Therapeutic Programs

100+

Countries

Experience measured in consequential decisions.

Evidence dossier / 10

Work across products involved in the 10 fastest FDA approvals is a defining point of difference.

Strategic advantages

Ten reasons, one standard of judgment.

10 fastest FDA approvals
01
Evidence note

We Solve Problems

We help clients overcome challenges and create regulatory strategies and pathways that result in first-cycle approvals.

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02
Evidence note

We Help You Avoid Pitfalls

We translate discoveries from the research bench and shepherd them through development challenges until they reach the patient at the bedside.

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03
Evidence note

We Are Transformative

We transform nonclinical and clinical results into optimized or new pathways, supporting faster reviews and earlier patient access.

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04
Evidence note

You Gain Critical Insights

We deliver critical insight into regulators' thinking at every step of the product development cycle and have optimized hundreds of programs.

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05
Evidence note

Unmatched Strategic Expertise

Our regulatory experts bring global experience across regions, development types, pathways and routes of administration.

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06
Evidence note

We Deliver Wins for Clients

From rescuing programs with devastating results to shortening review and development time, our work saves time and money—and supports years of patient quality of life.

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07
Evidence note

Breakthrough Regulatory Strategies

Transforming nonclinical and clinical data into new regulatory pathways from concept to commercialization is our major differentiator.

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08
Evidence note

Accomplishments Drive Us

Collaboration at the forefront of clinical science drives us to transform available data into paths forward.

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09
Evidence note

A Unique Perspective

Prescribers, former sponsors and former reviewers from across the world position us to accelerate the path to approval.

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10
Evidence note

We Help Fuel Your Growth

We have helped startups launch first products, supported global brands across the lifecycle and advanced clinical-to-commercial pipelines.

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Signed perspective

Verified source statement

“GloboScience is the regulatory problem solver and product development consulting partner of choice.”

Lorna L. Langdon · Chairwoman
Point of view

The regulatory problem solver and product development consulting partner of choice.

Our solutions work because no two products or programs are alike. From a benefit-risk perspective, we distill scientific and clinical research into its essence so that a regulator gets it.

GloboScience is the regulatory problem solver and product development consulting partner of choice. — Lorna L. Langdon, Chairwoman

Put experience to work

Make the next decision defensible.

Share the regulatory decision, development challenge or pathway that needs experienced judgment.

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