Ocular Drug Delivery Solutions
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Medical Device Risk Management
4/28/2022
At Kymanox, we provide risk management solutions for medical device compliance with ISO 14971, Medical Device Directive (MDD) 93/42/EEC, and Medical Device Regulations (MDR). We partner with you and your team to develop strategic solutions to address the specific needs of your product. We provide support throughout the product development life cycle including development of a Risk Management File that incorporates risk analysis, hazard analysis, device monitoring, and more.
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Accelerate Development And Delivery Of Your Modern Medicines
4/28/2022
We are your life science solutions partner who ensures you have the right end-to-end solutions to address challenges in early development, commercialization, and post-market for your combination products, biologics, pharmaceuticals, and medical devices.
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Glass Prefillable Syringe Solution Delivering Complex Biologics
5/9/2022
BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.
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A CDMO With Oral Solid Dose And Sterile Injectable Expertise
6/6/2022
Societal specializes in modified-release formulations, including those for high potent and DEA controlled substances.
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Easy-To-Use 1 mL Disposable Autoinjector
6/8/2022
BD Physiojectâ„¢ 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.
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Pharmaceutical Aseptic Filling Equipment
6/29/2022
AST’s ASEPTiCell® and GENiSYS® systems combine industry-proven technologies such as robotics and isolator-barrier systems to provide flexible pharmaceutical aseptic filling and closing of ready-to-use vials, syringes, and cartridges with a single machine. These innovative platforms use a modular design approach to provide a truly adaptive system with the capabilities and features necessary for cGMP production of clinical and commercial sterile injectable products.
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Sterile Formulation Development
7/1/2022
With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.
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Drug Product Services: Pre-Formulation To Commercial-Scale Production
8/17/2022
Our experts support clients with pre-formulation, formulation, process and analytical development, as well as production and registration. We’ve worked on a range of both oral solid dosage and injectable projects for clients over the years.
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Biodegradable Polyester Amide Platform For Sustained Delivery Solutions
10/21/2022
A robust synthetic polymer platform based on naturally occurring amino acids, TheraPEA was designed to address limitations associated with the use of traditional polymeric materials.
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Aseptic Filling Systems For Biopharmaceutical Manufacturing
3/28/2023
AST aseptic filling products address the unique processing requirements of biologics manufacturing to gently care for biologic products during the fill-finish process. Their highly accurate peristaltic dosing system uses single-use pharmaceutical grade tubing that has been optimized to keep shear stress to an absolute minimum. When exiting the fluid path through the filling needle, the motion control system maintains the fill needle within the container and slowly rises as the product is being dispensed to minimize splashing and foaming that could introduce stress to the product. Temperature controlled filling is also possible with the ASEPTiCell® and GENiSYS® systems. AST has experience dosing products at temperatures as low as 3°C.