Regulatory Compliance Solutions
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Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer
6/20/2023
High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.
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Strategic Regulatory Documentation Practice
5/31/2023
Learn how this highly experienced and fully dedicated team is improving timeline creation complexities and management, resourcing, document interdependencies, and transmission to health authorities.
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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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Annex 1 Compliant Real-Time Viable Particle Counter
12/15/2022
What Is Annex 1 and Why Is It Important? Annex 1 is a GMP document published by the European Commission and dedicated to the manufacturing of sterile products. All pharmaceutical companies that produce sterile products must comply with these regulations. The document is a joint initiative between the EMA and PIC/S.
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Metrology Teams Collaborating With Waters
7/14/2022
Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.
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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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Electronic Batch Records
8/31/2021
Ensure compliance and improve efficiency by automating your paper-based systems.
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Enhance Product Safety With A Non-Destructive Leak Testing System
10/29/2023
Versatile CCIT1 for a wide range of applications
The SpeedAir 3050 is your all-in-one solution for nonporous pharmaceutical applications. Whether your products are flexible or rigid, liquid or solid, the SpeedAir 3050 can swiftly and accurately test them all. With testing times as short as 30-45 seconds, it delivers results you can rely on, ensuring the integrity of your pharmaceutical containers.
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What Does It Take To Guide A Combination Product Down The Path To Regulatory Submission?
As one pharmaceutical company learned, it takes support from the right partner to create an on-body device that can safely and reliably deliver their medicine—while empowering patients to take control of their own health.
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Cleanroom Capabilities And Expertise
Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.