Regulatory Support
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Comprehensive Regulatory Expertise
Our team collaborates closely with your organization to ensure that every step of development and manufacturing meets the stringent requirements of regulatory agencies such as the FDA, EMA, MHRA, and other global authorities. From preparing technical documentation to supporting agency interactions, we help you position your product for a smooth path to market.
We provide:
Regulatory strategy consultation
identifies optimal submission pathways and anticipates potential hurdles
CMC (Chemistry, Manufacturing, and Controls) support
ensures accurate, complete, and compliant data packages
Dossier preparation & review
includes authoring, reviewing, and compiling CTD/eCTD modules
Ongoing compliance monitoring
adapts to changes in guidelines and ensures continued market authorization
Your Advantage with Codis
With our depth of technical expertise and experience in supporting global product registrations, Codis acts as an extension of your regulatory team, reducing risk, avoiding costly delays, and ensuring your product meets every requirement.
Contact UsDiscover Codis
Explore how Codis applies its expertise in spray drying, microencapsulation, continuous granulation, final dosage forms, and functional products to meet your formulation and manufacturing needs.
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Commercial Spray Drying
Full lifecycle, development, and production expertise for high-volume commercial aqueous spray drying.
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Codis Amorphous Solid Dispersion (ASD)
Industry-leading know-how to design, scale, and manufacture amorphous solid dispersions for improved bioavailability of poorly soluble compounds.
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Microencapsulation
Proprietary microencapsulation processes to improve taste, odor masking, stability, or release profile.
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Continuous Granulation
Continuous high-shear granulation to improve flow, compressibility and disintegration.
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Organic & Polymer Chemistry
Advanced organic synthesis and polymer engineering, enabling robust, scalable manufacturing.
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Analytical Services
State-of-the-art instrumentation combined with data-science–driven PAT to provide method development, validation, release, and stability testing services.
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Final Dosage Forms
Leading global experts in direct compression and two-piece encapsulation products for vitamin, mineral and supplement markets.
Codis Insights & Updates
Stay current with the latest in particle engineering science and Codis articles and resources.
Connect with us to explore how our particle engineering, commercial spray drying, formulation, and advanced manufacturing capabilities deliver high-quality, dependable supply for even the most challenging products.