FDA Regulatory Consulting

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

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

Nonclinical Drug Development

Nonclinical studies begin well before a Sponsor’s first interaction with FDA and span throughout a product’s development. Having a robust nonclinical development program can help you avoid spending time and resources on studies that fail to address FDA’s issues of concern, and thus may need to be repeated.

Our nonclinical consultants help maximize your potential for success by designing pharmacology, pharmacokinetics, and toxicology programs that are appropriate to support the intended indication, route of administration, and duration of treatment for your product.

Clinical Development Consulting

Without the right clinical study data and an understanding of the relationship, New Drug Application (NDA) submissions may be perceived as incomplete or unsubstantiated. This can lead to unexpected delays in your product’s development, a need for additional studies, and financial implications. Our team of clinical consultants will help you implement a solid PK/PD program to facilitate a successful development program which will streamline FDA’s NDA review process.

Regulatory CMC Consulting

Chemistry, Manufacturing, and Controls (CMC) begins after a lead compound is identified through drug discovery and continues through all remaining stages of the drug development lifecycle. Our team of regulatory CMC consultants are scientists first and foremost, and our CMC consulting services can be tailored to meet your unique needs throughout the entire development lifecycle, from candidate selection through post approval and beyond.