GloboScience Inc.
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WHO WE ARE
Rapidly evolving scientific advancements and increasing regulatory uncertainty 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 experts in regulatory science, pharmacology, toxicology, clinical development, pharmacovigilance, medical affairs, manufacturing and biostatistics.
WHAT WE DO
Whether you have a product in nonclinical or clinical development, GloboScience implements an experience-based approach to provide strategic, scientific and regulatory services that results in first cycle 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.
WHAT WE'VE DONE
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 pharmaceuticals, biologics, medical devices, consumer health and new product development.
OUR EXPERTISE
• Pharmaceutical Drugs
• Biologics
• Medical Devices
• Bioimiliars + Generics
• Foods
OUR SERVICES
• Regulatory
• Clinical and Nonclinical Development
• Chemistry Manufacturing & Controls
• Biostatistics
• Pharmacovigilance
SPECIALTY
• Rare Diseases (Pathway Creation)
• Complete Response Letters, Rejections, Appeals (Regulatory Rescue)
• Indication Consulting (Optimized Development + Accelerated Filing)
Keywords
rare diseases & orphan products, biotechnology, regulatory strategy, regulatory science, product development, biologics, biosimilars & generics, oncology, vaccines, labeling, advertising, promotions, nonclinical, clinical development, quality management, gene therapy, cell therapy, biologics license application, marketing authorization applications, new drug applications, investigational new drug applications, immunotherapy
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