Regulatory

Our regulatory experience and expertise will help your organization achieve and maintain compliance as well as making compliance processes more cost-effective and efficient. Our engineers and regulatory specialists have expertise working with organizations of all sizes, with that expertise covering the laboratory, manufacturing, and QA (quality assurance) functions of pharmaceutical facilities.

We also have extensive technical expertise that we will use to modernize, optimize, and improve all aspects of compliance in your organization.

Our tailored regulatory support solutions will help you maintain compliance with FDA regulations, EU regulations, and regulations in other jurisdictions. We can provide end-to-end regulatory support services, compliance-specific technical support, or support that augments your existing quality and regulatory team.

Ensuring computer systems are compliant, utilizing technologies to automate compliance processes, and improving data accuracy, integrity, and availability are just some of the ways our team can provide regulatory support.

Tailored Compliance Support

• Reviewing, creating, and updating policies, processes, and SOPs (standard operating procedures) across both manufacturing and laboratory environments.
• Identifying and mitigating compliance risks.
• Lab informatics solutions that, among other operational and productivity benefits, help improve the audit readiness of your laboratory.
• Integrating manufacturing, laboratory, and IT systems to improve data collection, transmission, storage, reporting, and accessibility.
• Enhancing both laboratory and manufacturing system controls to improve data integrity and security.
• Consultancy services and compliance reviews to assess current compliance processes, technologies, and capabilities.
• Compliance technology implementations and upgrades.

• FDA, EU, and OUS (outside the United States) regulatory requirements.
• 21 CFR Part 11, the FDA’s regulations on electronic records and signatures.
• EU GMP Annex 11, the EU’s regulatory guidelines on using computerized systems.
• GAMP5, the best practice framework to ensure computerized systems are compliant, fit for purpose, and effective.
• GxP, the quality guidelines and best practices that include GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice).
• CSV (computer system validation) and CSA (computer software assurance), the guidelines and processes for validating computer systems.
• ALCOA+, the principles that ensure data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.

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