Web Content Management
PRODUCTS
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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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Modern clinical trials require modern technology. Leverage the flexibility and speed of the cloud with TrialKit electronic data capture(EDC).
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Werum PAS-X as a Service delivers a fully managed, cloud-based MES for pharma and biotech, enabling rapid deployment, scalability, cost savings, compliance, and operational efficiency.
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ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.
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Elevate Your Clinical Research Data Collection
WHITE PAPERS AND CASE STUDIES
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OPTICHECK Technology Built-In – Diagnostics, Verification, And Functional Safety With OPTIMASS Coriolis Mass Flow Meters
State-of-the-art measuring devices such as OPTIMASS Coriolis mass flow meters combine robust measuring principles and powerful electronics to produce a wide range of readings and device-specific data. OPTICHECK technology built-in leverages the features of the devices to translate their available comprehensive measuring system data into sophisticated diagnostics information for plant personnel.
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Understanding Biosafety Levels
Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.
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Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals
VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.
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Clinical Phase Manufacturing With A Self-Contained Cleanroom Facility
Explore the development of a mobile Biosafety Level 2+ (BSL-2+) facility adhering to cGMP for early-phase clinical trial manufacturing.
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Tackling Antimicrobial Resistance
Learn how three companies collaborated to develop a new antibiotic to address the increasing development of antimicrobial resistance (AMR) that threatens the global health landscape.
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Providing Packing And Blinding Solutions For An Innovative Drug Start-Up
Discover how a CDMO with integrated services enabled a botanical drug start-up to commence its Phase 1 clinical trial, paving the way for further advancement of its innovative botanical drug.
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Why A Leading Manufacturing Partner Chose NeoTOP Packaging Machines
Learn how a leading CDMO partnered with Körber to quickly deploy a high-speed packaging solution to meet tight production deadlines in the face of a global pandemic.
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Not Your Typical MES: The Ultimate Guide To Made With MX
Life sciences manufacturing is evolving rapidly. Discover how digital transformation is revolutionizing production processes to enable personalized medicine and improve patient outcomes across the healthcare industry.
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AMERICAN SpiralWeld Pipe Delivers For City Of Phoenix Drought Pipeline Project
Phoenix’s Drought Pipeline Project, supported by AMERICAN SpiralWeld Pipe, secures clean water for North Phoenix, delivering up to 75 million gallons daily and earning top industry awards.
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Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy
Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.
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The Evolution Of Clinical Operations And The Growth Of FSP Partnerships
Explore the integration of new technologies, the FSP’s role in promoting patient diversity, and how clinical operations leaders are increasingly becoming thought leaders within the industry.
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Revolutionizing European Football With UWB Micro-Location
See how UWB micro-location technology was utilized by European League Football to address pandemic-era challenges, but quickly transformed into a vital tool for player analytics and safety monitoring.
NEWS
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Tribun Health Achieves FDA Clearance For Calopix Digital Pathology Platform With Dual Scanner Compatibility5/21/2025
Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management system, CaloPix, has received FDA 510(k) clearance for use with two leading whole slide imaging scanners: the Hamamatsu NanoZoomer S360 and the Leica Aperio GT450.
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Alvotech Appoints Dr. Balaji V. Prasad As Chief Strategy Officer3/27/2025
Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced the appointment of Dr. Balaji V. Prasad as Chief Strategy Officer.
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Biodesix Recognized As A Thermo Fisher Scientific Center Of Excellence (COE) For NGS Diagnostics8/19/2025
Biodesix, Inc. (Nasdaq: BDSX), a leader in personalized diagnostics, announced that the company is designated as a Thermo Fisher Scientific Center of Excellence (COE) as part of Thermo Fisher’s collaborative initiative to advance NGS-based diagnostics.
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BIoNTX And The Cleanroom Center Launch Strategic Hub For Drug Manufacturing In Dallas7/28/2025
The Cleanroom Center has launched its global headquarters in Dallas, partnering with BioNTX to help life science and advanced manufacturing companies accelerate cleanroom selection and deployment
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Reusable Nanofiber Membrane Filters Water Sustainably10/23/2025
The antimicrobial triclosan is widely used in personal hygiene products, textiles and plastics, but when it enters the environment via wastewater, it poses a significant threat to aquatic organisms.