We are a collective of the best and brightest, comprised of thought leaders who have been there and done that. We find the “it” that supports an innovative regulatory pathway. Our direct access to a network of key opinion leaders, regulators and executives, enable us to deliver success outcomes for our clients. We are passionate about rare diseases and curious about novel science.
From the laboratory to the approved product label, our expertise and influence extends globally.
We’ve worked in all therapeutic areas, with all technologies, in all routes of administration, with all dosage forms, and with all company types and of all sizes. From the laboratory to the approved product label, our expertise and influence extends globally.
While stakeholders influence approvals, pre and post-market adverse events directly affect the availability (approvals) of new medical products. These safety indicators act as regulatory cues for product development and are good predictors of regulatory conservatism.
We are an invaluable partner in the field of life sciences and create regulatory pathways where no precedent or guidance exists. Our solutions and strategies to regulatory challenges work because no two products or programs are alike. From a benefit and risk perspective, we distill your 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.”
Chairwoman
Therapeutic Programs
Health Authority Meetings
Countries
Our experience working with products that comprise the 10 fastest FDA approvals, is our point of difference! Here are just a few reasons to choose GloboScience:
At GloboScience, we solve problems, we help you overcome challenges, we create regulatory strategies and pathways that results in first cycle approvals.
We translate our client’s discoveries from the research bench and shepherds it through the myriad of challenges while avoiding pitfalls until it reaches the patient at the bedside.
Transforming our client’s nonclinical and clinical results into optimized or new regulatory pathways is what we do best. This translates into faster reviews, first cycle approvals, and products reaching the hands of prescribers and patients sooner.
GloboScience has delivered sage and critical insights into regulators thinking for our clients at every step of the product development cycle across therapeutic areas, routes of administration and product types. We have successfully optimized hundreds of development programs for the medical products industry.
Our team of strategic regulatory experts bring a level of global experience and insights that are immeasurable (across geographic regions, development types, pathways and routes of administration). We are proud to have worked on the 10 Fastest FDA approved drugs during their life cycle.
From rescuing programs with devastating clinical trial results or unfavorable health authority minutes, to optimizing clinical development programs and achieving shorter review and development time, we save our clients time and money, which translates into years of patient quality of life.
Our expertise in transforming data from nonclinical and clinical development while levering these data to forging new regulatory pathways for medical products from concept to commercialization is unparalleled and our major differentiator.
Collaborating with clients at the forefront of clinical science drives us. Our expertise in transforming and leveraging available date to forge new regulatory pathways for medical products from concept to commercialization is unparalleled and our major differentiator.
Our unique perspective as a mix of prescribers, former sponsors and former reviewers from all regions of the world, coupled with our international success in guiding development programs makes us distinctly positioned to accelerate your path to approval.
We’ve helped startups launch their first approved products. We’ve helped globally recognized brands along their product lifecycle and advanced our clinical-to-commercial client’s pipelines and fuel their growth.
We’ve worked in all therapeutic areas, with all technologies, in all routes of administration, with all dosage forms, and with all company types and of all sizes. Explore our case studies
We believe in regulatory science and medical product development as a weapon to fight disease and improve health outcomes.
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