Regulatory Sciences

The World’s Leading Regulatory Science Consultancy

ProPharma's aim is to help your business succeed by working to streamline the pharma/biotech/medical device regulatory process. Our experienced team of regulatory consulting and compliance experts commands an unparalleled breadth and depth of knowledge pertaining to the US and European regulatory frameworks and can work with you to accomplish your business objectives. Using our deep scientific knowledge combined with our significant regulatory experience, our Regulatory Sciences team develops and executes detailed strategies for your product, providing a clear path forward through all the critical milestones to help you achieve a successful outcome with the regulators.

We support post-authorization regulatory pharma/biotech/medical device operations, including product launch, publications review, line extensions (LEs), and CMC changes. We maintain your products' optimal regulatory status throughout its lifecycle. Our track record of success in both the US and in Europe is unmatched. As the only true global regulatory consultancy our pharmacologists, toxicologists, chemists, and clinicians have helped hundreds of small and large firms successfully move their products from one regulatory hurdle to the next.

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.

Regardless of where you’re located, what Agency you’re seeking approval from, and where you are in the product lifecycle, our experts can help ensure you are set up for European regulatory success. Our team of European regulatory consultants is made up of a diverse group of experts, each of whom bring an unparalleled breadth and depth of knowledge pertaining to the regulatory frameworks of the European Medicines Agency (EMA) as well as the Local Competent Authorities.

Our regulatory affairs consultants will work with you to develop a detailed regulatory strategy, prepare for and conduct successful interactions with the applicable regulators, and/or develop and submit your regulatory submission(s) to the appropriate Agency.

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.

ProPharma’s team of European lifecycle management consultants will partner with your organization to act as an extension of your team. Our experts bring vast experience and a deep understanding of effective lifecycle management throughout Europe and have the knowledge to offer a complete regulatory solution for your product.

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

Having an effective Market Access and Reimbursement strategy is crucial to ensure commercial success for any product. A complete and well-thought through market access strategy will optimize revenue, sustain growth, and foster stakeholder collaboration.

ProPharma specializes in crafting bespoke Market Access and Reimbursement strategies, connecting groundbreaking medical solutions with those in need. Our collaborative, data-driven approach ensures successful market entry and sustainable expansion, all while putting patients first and considering global goals.

Are You Ready To Achieve Regulatory Success?

ProPharma is the leading regulatory consultancy in the world. Contact us today to lean how we can help you successfully achieve your global regulatory goals.

Benefits of Using a Regulatory Consultant

Choosing the right regulatory pathway is critical to the success of your regulatory submission. A good regulatory affairs consultant with global capabilities and experience will play a crucial role throughout the entire drug development process.

Some of the key benefits of engaging a regulatory consultant who is a scientific expert include:

Benefits of Engaging with a Regulatory Consultant

Expertise in the Development of Regulatory Strategies

Regulatory consultants provide the specialized scientific knowledge needed to develop and execute effective regulatory strategies that align with your overall business objectives.

Guidance Through Regulatory Processes

A good regulatory affairs consultant will help guide your company through the development and submission of regulatory dossiers and work with your team to achieve positive interactions with the regulatory agencies, ultimately leading to achieving successful regulatory outcomes for your organization and product.

Cost Management

Regulatory consultants assist the management of compliance costs by helping your organization avoid incurring the expenses associated with regulatory failures.

Adaptation to Regulatory Changes

Regulatory consultants help companies adapt to significant law, regulation, and guidance changes, ensuring continuous compliance across the ever-changing global regulatory landscape.

Implementation of Best Practices

With their scientific and regulatory experience, consultants bring industry best practices and standards to your project to address any potential challenges and prepare for new developments.

Support for Internal Teams

Regulatory affairs consultants will provide insight and support to your internal regulatory teams, helping implement and maintain processes and systems that are compliant and appropriate for your organization.

ProPharma: Expert Scientific and Regulatory Affairs Consultants

It is of the utmost importance that you take all precautionary measures to ensure that you are headed in the right direction. We can help you do this. ProPharma has significant experience in helping our clients determine the most appropriate regulatory pathway and then working to develop and submit the application to the FDA.

Using our unique approach that combines vast regulatory experience with a deep scientific knowledge, we have had overwhelmingly high success rates when dealing with the Agency. By partnering with us, some of the benefits you will receive include:

• Experience: We have been working directly with the FDA for more than 40 years
• Knowledge: We know what is required to achieve a successful interaction with the Agency and are uniquely qualified to work with you in preparing and submitting an extraordinary submission
• Diversity: Our team of scientific and regulatory experts specialize in a variety of disciplines and stay abreast of changing trends and current events within the industry. Thus, we can bring a unique and extensive range of knowledge and experiences to the table, which is exactly what is needed to develop an application that will be successful

Regardless of which regulatory pathway fits your development plan best, we’ll be there to ensure that your discussions with the FDA are properly framed to fit the chosen pathway and guide your product through the approval process.