Catalent Drug Development, Delivery and Supply
Whether you are looking for a single, tailored solution or multiple answers throughout your product’s lifecycle, we can improve the total value of your treatments—from discovery, to market, and beyond. Browse our integrated services by dosage form.
- PRECLINICAL
- PHASE 1
- PHASE 2
- PHASE 3
- Commercial
Preformulation and First in Man Clinical Supplies
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Preformulation and First in Man Clinical Supplies
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With development capability for both small and large molecules, we provide complete CMC services for oral, inhalation and sterile product from preformulation thru clinical supply.
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Scale-up, Validation, and Clinical Supply
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Scale-up, Validation, and Clinical Supply
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We provide complete CMC services for oral, inhalation, and sterile products from formulation through clinical supply, including scale-up and technology transfer to our commercial manufacturing facilities.
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Global Commercial Supply Offerings
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Global Commercial Supply Offerings
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Our superior facilities, broad offerings, and unique, proprietary delivery technologies enable us to supply you with the most successful and cost-effective products for your treatments.
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Optiform Solid State Services
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Optiform Solid State Services
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Catalent will discover and evaluate the diversity of solid-state forms of your API, enable the selection of the most suitable forms to meet your development needs and ensure a successful, timely and cost-effective progression of your API from pre-clinical and clinical development thru commercialization.
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Formulation and Development Programs
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Formulation and Development Programs
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We are a global leader in drug development and delivery, with a team of over 1,000 scientists and over 100 years of combined experience, we can help enhance the therapeutic profiles of your products, providing you with better treatments.
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Line Extensions and
Re-Formulations-
Line Extensions and Re-Formulations
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With our broad offerings and proprietary delivery technologies, we have the capability to help create unique formulations leading to potentially patentable line extensions.
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Dose-form Selection and Drug Delivery Technologies: Softgel, Controlled Release,
Modified Release, Fast Dissolve and more-
Drug Delivery Technology
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Using our advanced technologies we can create tailored solutions for your toughest drug development challenges. We have deep scientific, regulatory, and product development expertise that will help improve the performance of your products.
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Bioavailability, Patient Adherence, Release and Therapeutic Profile Optimization
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Better Treatments
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We offer the broadest range of proven solutions to improve bioavailability, deliver better absorption, controlled API in blood levels, faster onset, extended release and targeted delivery, and improved patient adherence.
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Integrated Commercial Packaging
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Supply Chain Solutions
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With our expertise and capacity across every phase of development, we offer you the peace of mind that comes from having one company manage your supply chain throughout your product’s entire lifecycle.
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Comprehensive Expert Analytical Support and Lab Services
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Analytical Lab Services
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From rapid testing of early candidates to New Drug Application (NDA) submission, we help accelerate your efforts by providing immediate resourcing and technical expert support for your product.
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Global Regulatory Support and Consulting Services
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Regulatory Consulting
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We offer comprehensive regulatory, clinical, and product development consulting services to help minimize your product's development time and maximize its time on the market.
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Global Comparator Sourcing, Clinical Packaging, Labeling, Kitting and Logistics
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Clinical Supply Services
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Changes occur frequently during the development phase that require unique solutions and a high degree of flexibility. Catalent’s expert teams offer creative solutions and provides the flexibility necessary for your clinical trial success.
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GPEx® Cell Line Engineering
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GPEx® Cell Line Engineering
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Faster, more reliable, and more flexible than traditional methods of gene insertion, GPEx® technology can ensure that genetically stable cell lines are produced 100% of the time.
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Development and Formulation
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Development and Formulation
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With over 75 years of experience developing world-class formulations for innovators around the globe, Catalent has the scientific, regulatory, and product development expertise to support a vast range of projects – from oral to inhalation to sterile.
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Biomanufacturing
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Biomanufacturing
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Whether you are using a Catalent GPEx® technology-based cell line or a client-derived cell line, we can design a process for your project that can be easily transferred to our production plant.
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Comprehensive Expert Large Molecule Analytical Support and Lab Services
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Analytical Support and Lab Services
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We have constructed a strong continuum of services to support our customers' development of biotherapeutic drugs built upon a foundation of innovative and enabling technologies, state-of-the-art manufacturing systems, and testing laboratories.
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Fill/Finish: Blow/Fill/Seal, Vials, Pre-Filled Syringes
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Sterile Fill/Finish Overview
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We can provide expertise in process design and scale-up, assurance, validation, and regulatory support for virtually any sterile dosage form using our technologies such as Blow/Fill/Seal and an array of advanced Injectable options.
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Integrated Commercial Packaging
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Supply Chain Solutions
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With our expertise and capacity across every phase of development, we offer you the peace of mind that comes from having one company manage your supply chain throughout your product’s entire lifecycle.
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Global Regulatory Support and Consulting Services
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Regulatory Consulting
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We offer comprehensive regulatory, clinical, and product development consulting services to help minimize your product's development time and maximize its time on the market.
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Global Comparator Sourcing, Clinical Packaging, Labeling, Kitting and Logistics
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Clinical Supply Services
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Changes occur frequently during the development phase that require unique solutions and a high degree of flexibility. Catalent’s expert teams offer creative solutions and provides the flexibility necessary for your clinical trial success.
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Preformulation and Optiform™ Solid State Services
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Preformulation and Solid State Services
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With integrated development capability, we provide complete CMC services for oral, inhalation, and sterile products from preformulation through solid-state services with our Optiform™ Technologies.
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Formulation and Dose Form Development
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Formulation and Dose Form Development
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With over twenty years in inhalation product development, Catalent has the broadest range of development services across all inhaled dose forms.
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Clinical Manufacturing
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Clinical Manufacturing
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Complete clinical trials materials preparation in support of Phase I - IV studies for all pulmonary and nasal dosage forms and seamless technology transfer to our commercial manufacturing facilities.
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Extractables & Leachables
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Extractables & Leachables
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We utilize state-of-the-art instrumentation for characterization of pharmaceutical entities, elucidation of chemical structures, and analysis of extractables/leachables.
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Comprehensive Expert Analytical Support and Lab Services
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Analytical Lab Services
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From rapid testing of early candidates to New Drug Application (NDA) submission, we help accelerate your efforts by providing immediate resourcing and technical expert support for your product.
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Global Regulatory Support and Consulting Services
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Regulatory Consulting
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We offer comprehensive regulatory, clinical, and product development consulting services to help minimize your product's development time and maximize its time on the market.
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Global Comparator Sourcing, Clinical Packaging, Labeling, Kitting and Logistics
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Clinical Supply Services
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Changes occur frequently during the development phase that require unique solutions and a high degree of flexibility. Catalent’s expert teams offer creative solutions and provides the flexibility necessary for your clinical trial success.
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