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Initial considerations for your marketing application need to be in place and planning initiated before your Phase III studies begin. We will work with you from beginning to end, to ensure that your global submissions are complete, timely and successful.
Submitting a marketing application is a daunting task that requires a multi-disciplinary approach involving strategic up front planning, critical analyses, efficient submissions, timely submissions and efficient follow up. It is a lengthy and complex pathway, requiring a tremendous investment in personnel and financial resources. It is important to work with a partner that integrates seamlessly with your team, and that you trust to provide the guidance and documentation that will get your product on to the market within the timelines specified.
Submission of a marketing application according to CTD to comply with standard guidelines and procedures (National, MRP, DCP, Centralized) requires a multi-disciplinary team. We have the flexibility to provide a comprehensive integrated service to deliver the entire submission under your guidance, or alternatively standalone services to supplement your internal team, as needed.