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CDMO Regulatory Support Services

Terumo Medical Care Solutions – Pharmaceutical CDMO provides its customers with comprehensive regulatory support spanning the entire drug development lifecycle from preclinical to commercial phases based on decades of experience as a manufacturer of sterile injectable products. We develop and design manufacturing processes that align with U.S. Food and Drug Administration (U.S. FDA), European Medicines Agency (EMA), PMDA (Japan) and ICH guidelines, ensuring GMP compliance throughout the process*.

* Regulatory status may vary site by site of Terumo CDMO. For detailed regulatory status of each plant please contact Terumo.

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Description
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Characteristics
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Activities
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Integrated CDMO Services
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Downloads
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Terumo CDMO Regulatory Support Activities
  • Regulatory strategy and gap analysis to align with regional requirements.
  • Preparation of CMC sections for regulatory filings in filing ready formats.
  • Contribute to responses to regulatory agency queries.
  • Employ phase appropriate quality assurance systems and validation protocols to meet inspection standards.
  • Stability studies, analytical method validation, and process validation to support injectable product shelf-life and safety claims.
  • Technology transfer oversight to maintain compliance during scale-up and commercial launch.
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Terumo CDMO Regulatory Support Activities
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By embedding regulatory compliance considerations into all development and manufacturing activities, Terumo Pharmaceutical CDMO helps pharmaceutical and biotechnology customers to reduce their approval risks, accelerate their timelines, and achieve global market readiness for their contract manufactured parenteral products.
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Primary Container Manufacturing (PFS)
/content/psd-ia/en/cdmo/primary-container-manufacturing
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CDMO Drug Product Development and Formulation
/content/psd-ia/en/cdmo/drug-product-formulation-development
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CDMO Aseptic Filling
/content/psd-ia/en/cdmo/aseptic-filling-visual-inspection
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Drug Delivery Device Assembly CDMO Services
/content/psd-ia/en/cdmo/device-assembly
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CDMO Labelling & Packaging Services
/content/psd-ia/en/cdmo/labelling-packaging-palletizing
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CDMO Regulatory Support Services
/content/psd-ia/en/cdmo/regulatory-support
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Parenteral CDMO Services at Terumo Pharmaceutical
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Download the Terumo Pharmaceutical CDMO services brochure to learn more about how we can support your parenteral drug development and manufacturing requirements with integrated innovative service solutions. From vials to prefilled syringes (PFS) at virtually any scale, we offer integrated CDMO services that deliver.
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CDMO Brochure
/content/dam/terumo-dam/internet-cms/en-emea/tmcs/psd/information-center-assets/brochures/terumo-pharmaceutical-solutions-integrated-cdmo-brochure.pdf
Download Brochure
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Contact

Contact Terumo Pharmaceutical About Parenteral CDMO Services

We help to bring your valuable injectable product to market with our integrated parenteral CDMO services. Accelerate the process of bringing your injectable product to the patients that need them with Terumo Pharmaceutical’s CDMO services today.
Contact Us
Contact Us
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