Global Regulatory Consulting

Moving you to the next phase

Premier Consulting offers full-service strategic product development and global regulatory expertise in all stages of drug development. Their regulatory consultants are with you throughout the development of your drug, biologic, device, drug-device combination, or diagnostic product. Their regulatory consulting services include:

• Extensive experience with agency interactions, averaging 75-plus meetings per year
• Consulting services aligned with agency thinking on drug/biologics/device development requirements
• Functional services such as acting head of regulatory for start-up companies
• Preparation and review of clinical protocols, CMC amendments, and response to agency questions
• Commercial solutions that maximize the potential of your program throughout development and the commercial lifecycle
• Publishing and document management experience, including significant work with new drug applications, biologics license applications, marketing authorization applications, and rest-of-world submissions
• eCTD submission process and expertise at every step of the approval process

From discovery through post-marketing, Premier Consulting supports strategy, trial design, regulatory submission, and compliance and has extensive experience preparing customers for major submissions and agency meetings.

The experienced Premier Consulting team can develop your:

• Strategic development plans
• FDA meeting preparation
• Nonclinical program
• IND and marketing application preparation and submission
• Orphan drug, breakthrough, and fast-track applications
• Clinical study design
• Clinical study reports
• Global safety database design
• SAE reporting

From early-phase to late-stage development, Premier Consulting’s global product development team leaders synchronize multidisciplinary services, global development expertise, and insight from therapeutic thought leaders to create development strategies custom-fit to your needs.