regulatory sciences

FDA Regulatory Consulting

Careful preparation for each FDA milestone and possible challenge is critical or your entire development and marketing strategy could be derailed. Planning is key to this process, and knowledge of FDA's intricacies and how the Agency works is a major plus.

Whether you need help developing and/or executing your entire regulatory strategy, developing an FDA submission, producing an FDA briefing package, or preparing for and conducting an FDA meeting, ProPharma’s experience and positive working relationship with the FDA means we will get the job done right. Over the last 40 years, our team of FDA consultants have established a proven track record with the Agency and will work with you to do what is necessary to move to the next milestone.

FDA Submissions

ProPharma’s Regulatory Sciences team offers expert guidance and FDA submission support throughout the entire product development and launch processes. With over 40 years of experience, we will plan and coordinate every detail of a clear and complete FDA submission. We’ll utilize our extensive regulatory and scientific experience, coupled with our strong relationship with FDA, to optimize the entire submission process. We provide regulatory affairs consulting services for key FDA regulatory submissions, including:

• Investigational New Drug (IND) applications
• New Drug Applications (NDAs)
• Abbreviated New Drug Applications (ANDAs)
• Orphan Drug Designation (ODD) applications
• Biologics License Applications (BLAs)
• Investigational Device Exemptions (IDEs)
• 510 (K) submissions
• De Novo submissions
• Q submissions
• Pre-Market Approval (PMA) applications

FDA Meeting Consulting

When conducted effectively, you should leave an FDA Meeting with answers to critical questions and an understanding of the Agency’s expectations. To achieve these goals, your meeting must be carefully planned and flawlessly executed. ProPharma’s team of FDA Meeting consultants has significant experience planning and executing FDA Meetings, including:

• Pre-IND Meetings
• End of Phase 2 (EOP2) Meetings
• Pre-NDA Meetings
• Pre-BLA Meetings
• FDA Advisory Committee Meetings
• Type A, B, C, and D Meetings

European Product Development

Successful regulatory interactions are key to your product’s success throughout Europe. From the earliest stages of development, careful planning and preparation is critical to achieve your ultimate regulatory goal: marketing authorization of your product.

European Lifecycle Management

After approval of your Marketing Authorisation Application (MAA) in Europe, you are required to remain compliant with all regulatory requirements to keep your product on the market. This includes, post-authorisation commitments, line extensions (LE) and variations, renewals, and much more. A strategic approach to European lifecycle management is critical for your success and to maximize your product’s potential.

Advertising & Promotional Review

ProPharma has built the world’s leading and first, full-service organization dedicated to global Advertising & Promotional Review services. Led by industry veterans and thought leaders, we help our clients develop compelling and compliant messaging in an efficient manner to grow their brands. With comprehensive promotional review capabilities – from Medical and Regulatory Review, technology solutions, marketing operations, to regulatory submission, and beyond – we take a flexible approach to meet our clients’ business objectives.

Market Access & Reimbursement Strategy