The ever-changing global regulatory environments require deep understanding of key success drivers in order to define and implement regulatory strategies that deliver against your business goals.

Novumed's regulatory team combines their expertise in successful regulatory submissions for pharmaceutical and medical technology companies with clinical and strategy consulting experience.

This unique multi-dimensional view allows us to work with you in mapping a regulatory roadmap that accelerates your drug-and device development. We can help you optimize your organizational and financial efficiency through:

§  Identification of regulatory and clinical options for acceleration of your drug or device development

§  Trial design customized for various submission options

§  Establishing communication strategy and briefing packages for authority meetings; efficient management of agencies FDA, EMEA and the Japanese MHLW through key relationships with former members

§  Support during all phases of interactions including dossier preparation and submission in national, mutual recognition, centralized and de-centralized procedures.

§  Suite of regulatory intelligence and writing services

Novumed has full eCTD capabilities and we can publish compliant electronic drug development reports as well as support eCTDs throughout the submission lifecycle.