Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Successful Regulatory Submission Via The Trifecta Of Awesomeness
Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.
Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing
Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.
A Practical Packaging Components Checklist For Emerging Biotechs
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations when selecting components for your injectable drug product.
How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows
The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.

Characterizing The Effects Of Moisture On Pharmaceutical Materials
12/30/2024

Moisture impacts pharmaceutical ingredients’ stability and efficacy, causing phase changes and hydrate formation. Discovery SA enables humidity and temperature profiling for improved drug formulation.
The New Annex 1 Regulations – Why Is It Important And How Can We Help?
10/21/2024

The new Annex 1 regulations will significantly impact facilities and companies globally, requiring a comprehensive Contamination Control Strategy (CCS). Learn how to navigate these changes and ensure compliance.
AI Implementation To Enhance Quality
2/11/2025

Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
The Pathway To Operational Readiness
6/24/2025

Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.
Environmental Monitoring Vs. Good Aseptic Technique
4/23/2024

Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.

Regulated Document Review

Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.
Commissioning, Qualification, Regulatory Compliance Services

We help you implement innovative approaches that help you achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and an integrated, business focused approach to regulatory compliance.
Sterility Testing For A Connected Era

This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.
Sterile Cleaning Swabs

With more than thirty unique foam, polyester, and cotton swabs available, our CONSTIX^® swabs product line offers a solution to almost any swab application challenge. Every CONSTIX swab has been designed with different lengths, head sizes, and materials to meet very specific customer needs.
Metrology Teams Collaborating With Waters

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.