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Regulatory Support: Navigating Your Path to Market
Terumo Pharmaceutical Solutions provides comprehensive regulatory support to its partners based on over a century of innovation in medical device and drug delivery technologies. Our regulatory experts help to guide customers through complex regulations and compliance requirements for our portfolio of drug delivery systems. Whether it’s providing robust device data to leading regulatory bodies in support of a device’s regulatory approval or even providing additional device documentation to regulators in support of a specific customer filing, Terumo Pharmaceutical Solutions has the experience and expertise to navigate customers towards their ultimate goal, approval.
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Introduction
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Regulatory Frameworks
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Our USPs
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What We Support
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Regulatory Support for CDMO
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Our Process
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Proven Success
Our Proven Regulatory Success
Terumo Pharmaceutical Solutions has a long track record of providing the data, documents and results needed to meet the needs of most major device regulatory bodies around the world. Selling medical devices into more than 50 countries worldwide, our network of associates provides local expertise along with intimate knowledge of the regulations and processes required for advancement in multiple regions.
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- European Union (EU)
Deep understanding of current Medical Device Regulations (EU 2017/745) for combination products and CE markings in the European Union. - United States of America (U.S. FDA)
Well versed in the Food, Drug and Cosmetic Act (FFDCA), CFR Title 21, and Quality Management System Regulation (QMSR) regulations governing drug delivery and medical devices in the United States of America. - United Kingdom (MHRA)
Experts in UKCA and CE markings and forthcoming regulations in the United Kingdom. - Japan (PMDA)
Japanese regulatory experts provide a full range of regulatory support for PMDA filings. - APAC Region
Across the Asia-Pacific region, Terumo has successfully obtained market authorizations in numerous countries including Australia (TGA), China (NMPA) and India (CDSCO). - Other Key markets
Terumo has obtained regulatory approvals in various other markets around the world including Africa, Canada, Latin-America and the Middle East among others.
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Terumo Regulatory Support
What Sets Our Regulatory Support Apart
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Keeping Current
Terumo regulatory experts keep up to date with the most current regulations, study new or pending regulation proposals and participate in industry regulatory associations, such as MedTech Europe.
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Problem Solving
At Terumo Pharmaceutical Solutions we go beyond just providing data and documentation for filings. Our experts help us to anticipate potential regulatory challenges and suggest solutions based on years of device regulatory experience.
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Detailed Documentation
We provide meticulously prepared data and documentation directly to the regulators in the required format for each specific application.
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Global Track Record
Our track record of successful submissions spans the globe, which derisks your regulatory pathway.
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Partnering to Market and Beyond
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We support you through every critical regulatory phase, from your initial submission to your post-market activities.
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Dossier Preperation Support
Support your regulatory dossier preparation through the provision of clear device related information.
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Addressing Regulator's Requests
Providing timely and informed responses to regulatory body inquiries regarding Terumo products.
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Post-Approval Support
Ongoing support for your regulatory changes, your variations, and your vigilance activities.
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Global Regulatory Submissions
Guidance and documentation to support your submissions in diverse international markets.
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CDMO Regulatory
Terumo CDMO Regulatory Support Services
Terumo Pharmaceutical Solutions provides comprehensive regulatory support for its CDMO services. Sterile fill-finish of vial or prefilled syringe (PFS) formats requires significant documentation for the CMC section of your filing. We have the expertise to fulfill the regulatory and compliance needs of the customer products produced through our sterile injectable contract manufacturing and development organization (CDMO) services.
Terumo CDMO Services
Terumo CDMO Services
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Our Process
Terumo Streamlined Regulatory Support
- Initial Assessment & Strategy
We begin by generating and in-depth understanding of your parenteral product, target markets, and specific regulatory needs to develop a personalized support strategy. - Documentation & Data Provision
Terumo Pharmaceutical Solutions’ regulatory experts meticulously compile and provide the necessary manufacturing data, quality documentation, and technical files required for your submission. - Submission Support
We support your team during the actual submission process, offering insights based on our experience with similar filings. - Inquiry Response & Liaising
Terumo Pharmaceutical Solutions’ regulatory support teams assist in preparing responses to questions from regulatory agencies and leverage our experience in interacting with these bodies. - Ongoing Compliance
Even after you’ve gained approval to launch your parenteral or injectable product, we help you maintain compliance through post-market surveillance data and support for product lifecycle changes.
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Contact
Connect with Our Regulatory Experts Today
Pharmaceutical and biotechnology companies partner with Terumo Pharmaceutical Solutions to bring their latest parenteral drug delivery innovations to life. If you have any regulatory questions about how we can support your development, manufacturing or drug delivery supply needs, reach out to us today.
Contact Us
Contact Us
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