Regulatory Guidance Check

Maintaining compliance with evolving regulatory standards is critical for preserving market access and ensuring product integrity. Our regulatory guidance check services are tailored to safeguard your existing marketing authorizations, Active Substance Master Files (ASMF), Drug Master Files (DMF) or manufacturing processes and analytical methods.

What can we do for you?

Our team begins by punctiliously identifying the sources that are most applicable for regulatory screening, including industry guidelines, regulatory authority publications, and other critical regulatory resources. We then regularly check these identified sources to capture any relevant updates or new regulations, ensuring that no important regulatory change is missed.

All changes are documented and stored in a comprehensive database, allowing for easy tracking and reference of regulatory updates. This ensures that your compliance records are always up-to-date. We create concise summaries of new and updated regulatory guidance, highlighting key changes and providing a clear understanding of how they may impact your products and operations.

Our experts can also support you by conducting thorough impact analyses to determine the implications of regulatory changes on your products and company. This analysis helps you understand the potential actions required to stay compliant. We also provide full support for implementing regulatory changes into your processes, quality systems, and strategies. This includes offering strategic advice, helping you revise documentation, and ensuring that all necessary adjustments are made efficiently and effectively.

By partnering with us for regulatory guidance check services, you ensure that your products remain compliant and optimized for regulatory success. Our expert team is dedicated to helping you navigate the complexities of regulatory requirements with confidence.

Contact us today to learn more about how our services can support your regulatory needs and enhance your compliance strategy.

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Kim Bruggink
Senior RA Manager

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Kim Bruggink
Senior RA Manager

Let's Connect

Talk to an expert