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Regulatory Affairs

Get Expert Assistance Meeting the Complex Challenges of Global Regulation and Develop Strategies To Minimize Risk and Maximize Benefit

Regulatory affairs play a leadership role in life sciences product development and lifecycle management, informing all functional groups involved in the process. A solid regulatory affairs team is paramount to understanding the dynamic regulatory environment, ensuring compliance, and advising on opportunities created by new and revised regulations.

Our professionals in the Americas, Europe, and Asia/Pacific assist clients in understanding and adhering to the regions’ regulatory requirements in which they conduct studies and market products.

Market Intelligence and Strategy

Our regulatory strategy consultants are mindful of regulatory updates in mature and emerging markets, helping our clients develop the right strategies to enter new markets and retain their edge in existing ones.

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Publishing

Our team of publishing experts provides end-to-end publishing services for electronic and non-electronic formats at a document and report level and submission to health authorities.

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SPL Conversion Services

Our experts support every label conversion requirement by preparing SPL submission packages for our clients with products in the US market.

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Global Regulatory CMC Services

Our experienced CMC team authors dossier sections for new applications and manage global change control requests, variation submissions, supplements, annual report submissions, and renewals.

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Company Core Data Sheet Management Services

Our global multi-disciplinary teams develop high-quality company core data sheets and create the framework for its maintenance during its lifecycle.

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Labeling and Artwork Management

Our local and global labeling hubs create and maintain labels and artwork with unparalleled market intelligence, deep-domain expertise, and deep product knowledge.

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Legal Entity Alignment

Our global regulatory operations have helped our clients manage the evolution of their organizations as they merge, acquire, or divest their brands and product portfolios in emerging and mature markets around the world.

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Regulatory Information Management

Our regulatory data experts support applications for variations, renewals, supplements, and annual report submissions, apart from xEVMPD submissions.

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Document Management

Our teams have experience in collating information from various sources and maintaining document versions to reduce the time taken to create dossiers and other regulatory documents for submission to health authorities.

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Product Registration Support

Our legal-regulatory teams prepare document packages for product registration in various markets based on our in-house regulatory intelligence and understand local nuances for new registrations, renewals, and tender participation, and more.

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