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Submissions consulting services

Submission Consulting Services include a process map and best practices gained from 100+ submissions across the pharmaceutical product life cycle. We can help identify planning and process gaps proactively, 12 to 18 months before submission target date and assist with the breakdown of a complex program into a manageable set of interrelated projects.

 

Medical writing

Our accomplished medical writers combine their talent and industry experience to provide the comprehensive support you need to meet global regulatory filing requirements. They combine their cumulative experience in regulatory writing with the communication skills required to prepare effective submissions.

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Project management

Our dedicated project managers work closely with diverse, multi-functional teams to ensure efficient delivery of quality documents and submission programs. Their attention to personal service, ongoing support of the combined project team, and focus on client interaction are key elements of each Audubon deliverable.

 

Quality control & quality assurance

Audubon offers a fully integrated and comprehensive QC/QA service for the entire spectrum of regulatory documents. This independent group relies heavily on the use of proprietary checklists, best practices, standard operating procedures, and high-powered editing tools to ensure the delivery of high-quality deliverables. Drawing from a vast amount of pharma industry QC experience, Audubon is especially well-versed in supporting complex submission dossiers.

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Publishing ready capabilities

Audubon's document publishing ready team can support the transition from MS Word documents to PDFs. Our services include support of complete MS Word and PDF publishing, bookmarking, and hyperlinking fully compliant with client's regulatory operating requirements. Our specialists are highly experienced industry professionals who understand the complexity of rapidly evolving digital requirements. Audubon project teams provide customized solutions to ensure publishing standards are met accurately in a cost effective manner.