Don't fear regulatory milestones. Demystify the regulatory journey to your drug or device approval.
Through our decades of experience, we've helped hundreds of companies understand the regulatory expectations for their drug, biologic, device, IVD, and combination products.
Our team's deep industry knowledge and regulatory expertise help you navigate the complex requirements and optimize your regulatory strategies.
Proactive guidance and risk management keep you on track to meet your program development milestones.
GLOBAL will collaborate with your team and subject matter experts to create a data-driven messaging strategy for all your documents. This approach ensures that both clinical decision makers and regulatory approvers can quickly access the most relevant product information. Our services include: content authoring, technical editing & formatting, QC review, document publishing, and project management.
Navigating the complex landscape of medical deviceregulations can be a daunting task for manufacturers, particularly with thestringent requirements of the European Union Medical Device Regulation (EUMDR). The EU MDR has significantly raised the bar compared to previous directives. GLOBAL can help you seamlessly adapt to these new regulations and other regulations in the medical device space.
Our consulting services include the following:
Whether you’re a start-up with a single pre-clinical asset or an established sponsor managing post-approval changes for your 20th, there are always decisions to be made. Having years of industry experience, GLOBAL’s strategic advisors will listen and collaborate with you to formulate the best regulatory, technical, and quality strategies to position you for success.
You don’t have unlimited time or resources. You need to get your product to market correctly, quickly, and on-budget. You might be asking yourself questions like, “How much data should I include with my pre-clinical IND?”, “How should I reply to that information request?”, and “We made some process changes, how do I know if I need a bridging study?”. The questions and challenges of launching a new product can feel endless.
At GLOBAL, we’ve seen it all and helped our clients through countless submissions. Count on us for your:
Our world-class scientists can guide you product from inception to bedside and through the many product and process development hurdles along the way. We apply our knowledge of health authority requirements, technical acumen, and industry best-practices to prepare strategies and technical documents that are fit for purpose, scientifically sound, and aligned with agency requirements.
Your quality management system is a living thing that requires regular maintenance. At GLOBAL, we'll work with you to create and maintain your quality system in a way that maximizes the value that you deliver to your customers, while keeping you compliant with industry requirements.
This 10-hour, interactive course provides an introduction to the basics of CER writing, with an emphasis on the practical interpretation of regulations and guidelines.
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