FDA Regulatory Consulting

Our FDA consultants develop detailed regulatory strategies for your product, providing a clear path forward through all the critical FDA milestones.

All of the members of our staff have been through multiple submissions and know how to use science to help drive your product through the regulatory process. In the past 15 years, all of our submissions have been successful. In every therapeutic area, in every type of product, our clients have gotten the feedback they wanted and the ability to move forward. From INDs, to BLAs, to priority vouchers and every type of FDA meeting, clients working with us have achieved their goals.

Explore all the ways that ProPharma’s Regulatory Sciences team can assist with all of your pharmaceutical regulatory affairs needs, supporting your product pipeline throughout the entire product lifecycle.

Our FDA Product Development & Regulatory Affairs Consulting Services

Regulatory Strategy & Gap Analysis Support

Your goal is to get your product approved and on the market in the most efficient way possible. To make this happen, you need a solid and effective regulatory strategy. Our team of Regulatory Sciences experts will work with you to develop a comprehensive strategy that will provide confidence in the forecast of key FDA milestones, necessary documentation, overall effort, cost, and a plan of action.

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.

Additional FDA Regulatory Consulting Services Include:

Regulatory Operations

Regulatory Operations is the support function responsible for handling all logistics associated with submitting an application to FDA. This includes document preparation, submission, and tracking of submissions to ensure they are compliant with all of FDA’s requirements from a technical perspective.

The nature of the role of Regulatory Operations has evolved significantly over the last decade. Since the FDA transitioned to electronic submissions, the role of Reg Ops teams has gone from a “nice to have” to a necessity. Today, there is a higher premium placed on having a Regulatory Operations team that is technically proficient and able to anticipate potential validation errors and rejection criteria, because there is increasing scrutiny on documents being received in the format the FDA prefers.

Medical Devices & Combination Products

As technology continues to improve and drive the world we live in, medical devices and their associated technologies are evolving as well. Although these developing technologies have led to significant advancements in modern medicine, they have also made it increasingly more challenging from a regulatory perspective. Regardless of where you are in the development or approval of your medical device, we can help with all of your FDA-related needs.