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PRODUCTS
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![GettyImages-849207658 Drug toxicity concept]( "NDA Submissions 505(b)(1) Or 505(b)(2)")
There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.
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![23 - Gator™ Photonic Component Cleaner]( "Gator™ Optical Fiber And Component Cleaner For Fusion Splicing And Termination")
Gator™ is a reusable, ergonomic cleaner for connectors, ferrules, bare fiber, PICs, and waveguides, supporting dry or wet cleaning. Sold in 50-packs.
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![ATUM sar sequence]( "DNA2.0 - Gene Optimization And Synthesis")
ATUM is building on DNA2.0's reputation for rapid, reliable and accurate DNA synthesis. Using our proprietary GeneGPS® and VectorGPS® platforms we design constructs optimized to express in your system, whether that's a single gene in E. coli, a metabolic pathway in yeast or a complex bispecific antibody in mammalian cells.
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![document file iStock-1212785891.jpg]( "Regulatory Operations")
At inSeption Group, our Regulatory Operations team brings together specialized expertise, advanced technology, and seamless collaboration to get your submissions right—the first time.
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![online document management-GettyImages-2161310407]( "Shorten Start-Up Times And Unify Clinical Applications")
Shorten start-up times for your clinical research studies by eliminating manual spreadsheets once and for all. SuiteSuccess for contract and clinical research organizations (CROs) allows you to unify clinical applications to improve visibility and oversight across the organization in one software platform. Now you can automate inefficient manual processes, from bid to bill, and deliver more quickly and more profitably than your competitors.
WHITE PAPERS AND CASE STUDIES
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![Scientists in lab-GettyImages-1441665026]( "Bispecific Antibodies Unleashed")
Bispecific Antibodies UnleashedExplore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.
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![GettyImages-1336251027 IT Specialist Using Laptop Computer In Data Center]( "Biotech Delivers A Superior Patient And Site Experience")
Biotech Delivers A Superior Patient And Site ExperienceTo become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
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![GettyImages-1834887136 aquarium]( "Delivering Water Biosecurity At Palma Aquarium Spain")
Delivering Water Biosecurity At Palma Aquarium SpainLearn how Palma Aquarium safeguards its delicate marine ecosystem with Atlantium’s innovative HOD UV technology, preventing disease outbreaks and protecting the environment.
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![Business Meeting-GettyImages-1831418247]( "Organizational Assessment For A Large MedTech Company")
Organizational Assessment For A Large MedTech CompanyExplore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.
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![bottle and syringe serum drug-GettyImages-1337025915]( "How Early-Stage Planning Strategies Are Optimizing Drug Development")
How Early-Stage Planning Strategies Are Optimizing Drug DevelopmentEarly integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.
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![GettyImages-1439780284 (1) milk bottling]( "Pasteurized Equivalent Water For AgriMark-Cabot Dairy In Vermont")
Pasteurized Equivalent Water For AgriMark-Cabot Dairy In VermontDiscover how AgriMark-Cabot Dairy transformed wastewater into a valuable resource using UV technology, achieving significant energy and water savings while maintaining stringent food safety standards.
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![GettyImages-172962854 screen]( "OEE And Product Inspection")
OEE And Product InspectionExplore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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![RZ3000-11]( "Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local Community")
Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local CommunityIn this case study, read how the Lunenburg Water District improved their water disinfection system with the installation of an Atlantium RZ300-11 HOD UV system. The system effectively disinfects water, meets future demands, and eliminates chlorine taste and odor.
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![Digital Checklist GettyImages-1465188429]( "Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning")
Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And CleaningThe piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
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![Solving The Silicone Challenge]( "Solving The Silicone Challenge In Pre-Fillable Syringes")
Solving The Silicone Challenge In Pre-Fillable SyringesDiscover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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![mcminnville]( "2nd Generation ATAD System Improves Capacity While Producing Odor-Free Biosolids")
2nd Generation ATAD System Improves Capacity While Producing Odor-Free BiosolidsUpgrade wastewater operations with automated aerobic digestion. This advanced process increases capacity and ensures stable temperature control for Class A compliance, producing odor-free biosolids and efficient nitrogen removal to meet strict environmental standards and community expectations.
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![online document management-GettyImages-2161310407]( "ProPharma Supports A Contract Manufacturer's Form 483 Response")
ProPharma Supports A Contract Manufacturer's Form 483 ResponseLearn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.
NEWS
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EPA Grants Arizona Primacy To Protect Underground Water Resources9/10/2025
Today, U.S. Environmental Protection Agency (EPA) announced a final rule approving the State of Arizona’s request to administer all classes of underground injection wells under the Safe Drinking Water Act (SDWA).
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ROHM Develops A 1kW Class High Power Infrared Laser Diode1/7/2025
ROHM Semiconductor today announced a new high output laser diode - RLD8BQAB3 - for use in ADAS (Advanced Driver Assistance Systems) equipped with LiDAR for distance measurement and spatial recognition.
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DigiCert Releases Latest Tools To Secure Digital Documents And Mitigate AI Fraud3/25/2026
DigiCert, a global leader in intelligent trust, today announced enhancements to its Document Trust Manager solution to help organizations combat rising document fraud, simplify global compliance, and strengthen trust in digital transactions in the age of AI.
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SIG Announces APR Design Recognized Recycle-Ready Bag-In-Box Package For Wine Featuring SIG Terra RecShield BD Laminate And SIG Terra FlexTap8/12/2025
SIG announced today that it has been formally recognized by the Association of Plastic Recyclers (APR) for meeting the highest criteria for recyclability under the APR Design Guide for Plastics Recyclability.
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Ericsson Unveils New Wave Of Radio, Antenna, And RAN Connect Products To Advance High-Performing Programmable Networks2/12/2025
As telecoms industry engagement with high-performing programmable networks ramps up globally, Ericsson is meeting related future needs through a significant product portfolio boost.