Strategy Consultation + Submission Planning

What to Know

For every pharmaceutical, from new Rx, OTC, generic, to “other," there are countless submissions, forms and data reports to be completed, reviewed and approved. That reality is an incentive to make sure everything is done right the first time.

For US drug marketing, the FDA Center for Drug Evaluation and Research (CDER) is the regulatory agency for safety and efficacy compliance.

Submissions to CDER must be made for ingredients, monographs, clinical research and testing ANDAs for new generic products, labeling and accompanying literature. A team of experienced regulatory specialists is the best practice approach to ensure approval.

How We Can Help

I3 regulatory consultants can structure all regulatory activities to align with your objectives. We have expertise in regulatory submissions and strategies—and we make sure they are properly prepared and positioned for your product. We routinely counsel and deliver full regulatory affairs management with:

• Prepare regulatory strategy
• Conduct submission planning
• Develop labeling strategy
• Obtain and manage clinical trial approval to support
• Humanitarian devices
• Orphan drug applications
• Competitor intelligence
• Medical writing
• Emerging regulatory change management
• Develop and execute global/regional strategies
• Develop contingency plans for full product life cycle
• Map, manage, prepare and execute all tasks to fulfill regulatory strategy