Regulatory Compliance Solutions
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Remote Cleanroom Microbial Air Sampler (Annex 1 Compliant)
12/1/2022
The MiniCapt® Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a Facility Monitoring System (FMS).
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Pharmaceutical Electronic Batch Records (EBR) Software
2/28/2023
CGMP software helps automate and standardize processes to get to market faster. GMP quality systems connect and ensure quality throughout the product life cycle. Information is maintained in a central location. Compliance is simple.
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Compliance And Validation Services For Waters Informatics Solutions
9/20/2022
We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.
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eCTD Submissions And Registrations Software
8/31/2021
MasterControl’s eCTD submission and product registration management software automates, simplifies and accelerates submissions and product registrations.
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MultiWash+ Microplate 96- And 384-Well Automated Washers
6/20/2023
Compact microplate washer with maximum flexibility in a minimum footprint
The MultiWash+™ Microplate Washer is an automated, compact, quiet, efficient washer with 20 different wash protocol options. The variations include adjustable speed and volume, adjustable aspiration speed and time, adjustable soak times, and three modes of shaking. Four wash/rinse bottles are included and configurable for both 96- and 384-well plates.
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Pharmacovigilance
7/6/2022
We support our corporate sponsors by providing both assessment and processing of SUSARS as per local and country requirements. We provide reliable reporting of adverse events, unbiased signal detection, and potential mitigation and risk management plans, based on any findings as requested.
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Compliance Program For EU Annex 1 Container Closure Requirements
Discover a program designed to comply with Annex 1 CCI requirements, focusing on vials, syringes, and cartridges. This holistic, science-based approach generates robust data throughout the product life cycle.
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Regulatory Services Offering
12/3/2023
Navigating the path toward regulatory approval is a complex process. Learn how partnering with Societal™ CDMO and leveraging regulatory expertise can empower your organization to achieve its goals.
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SecurityLink™ HPLC/UHPLC Fingertight Fittings
6/16/2023
The SecurityLINK fingertight fitting system simplifies your system and column connections and provides consistent performance with torque limiting technology that prevents column damaging overtightening.
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Continuous Monitoring Of Cleanrooms And Isolators
1/30/2020
FMS/BioTrak/Portable/Remote/Environmental Sensors