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Best practices help manage critical business processes including submissions management, labeling, digital asset management, pharmacovigilance case processing, clinical data management and analytics.
Our services are fully compliant with FDA guidelines and global quality standards while leveraging the latest digital technologies, helping you quickly adapt to changing business conditions.
Includes the evaluation of off-the-shelf products for Part 11 compliance, working with the Submission Process Re-engineering framework and evaluating the impact of global regulatory updates.
Serving customers by looking forward as well as back is a big promise, but the power of today’s new digital capabilities is vast and growing.
Let’s talk about how digital can work for your business.