From the beginning, medical writing, project management, quality services, and collaboration have been the foundation of our global success. In 2008, Gerald Hattrup launched Audubon PM Associates to support worldwide regulatory submissions for the pharmaceutical and biotech industry. Since our inception, we have supported over 100 submission delivery teams, spanning both small and large molecular compounds for new and established companies. Their trust has enabled Audubon’s growth into a 60+ Associate Team, brought together with the central mission of helping our clients to flourish and attain their goals.

 
 
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Our comprehensive service covers all aspects of consultative new drug submission planning, regulatory writing, project management, and production of quality submission-ready documents. We also support diverse therapeutic and disease areas, including dossiers for both CTD and non-CTD accepting markets. Whatever your needs, Audubon can help develop and implement submission communications strategies with the product label in mind, aligning key messages across critical clinical study reports and CTD summary modules.

Core to Audubon values is our commitment to people, innovation, quality, and our covenants—integrity, respect, and collegiality.

 
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A deep understanding of regulations and adherence to best practices allows us to anticipate your needs, adjusting quickly to unexpected changes in demands, circumstances, and timelines. Moreover, we provide continuity and streamlined communications by dedicating one of our most experienced associates to act as your personal point of contact. This approach smooths the submission process and delivers consistent results.

 

Audubon is committed to building long term partnerships with innovative pharmaceutical companies to attain new product approvals. With associates throughout North America, Europe, and Australia, we offer the agility, accessibility, and skills to exceed our clients’ expectations.