European Regulatory Submissions & Applications

Scientific knowledge to prepare compliant and viable European regulatory submissions to achieve successful outcomes.

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Regulatory Sciences Flywheel

World's Leading Regulatory Consultancy in Europe

With decades of experience with all product types, including drugs, biologics, and medical devices, our diverse team of experts possess a deep understanding of the regulatory landscape in both Europe and the US. We know what it takes to achieve successful marketing authorization in Europe.

Explore Our European Regulatory Submissions and Applications Services

At ProPharma, we share your commitment to getting innovative products on the market and in the hands of patients who need them most.

 

Expedited Pathways in Europe

ProPharma offers comprehensive expertise in navigating the evolving regulatory landscape in Europe to expedite the approval process for innovative products. In a rapidly changing environment, understanding the nuances of regulatory programs is crucial for sponsors seeking efficient development and market access. While the FDA's Accelerated Approval, Priority Review, Fast Track Designation, and Breakthrough Designation programs are well-known in the U.S., ProPharma emphasizes the need for clients to explore their European counterparts. The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) offer incentives, such as:

  • PRIME Designation
  • Conditional Marketing Authorization (CMA)
  • Accelerated Assessment
  • Exceptional Circumstances

Each of the European regulatory expedited pathways has distinct requirements. Accordingly, each of the pathways also provides Sponsors with its own unique benefits. 

ProPharma's in-depth knowledge extends to the PRIME (priority medicines) initiative, which provides accelerated assessment criteria and early Rapporteur appointments. Despite its potential, PRIME designation can be challenging to secure, and ProPharma guides clients through this process. CMA, analogous to U.S. Accelerated Approval, offers a route for products addressing unmet medical needs, but ProPharma emphasizes the importance of demonstrating a positive benefit-risk balance. The exceptional circumstances pathway recognizes the challenges posed by ultra-rare diseases, allowing flexibility while maintaining rigorous evaluation.

ProPharma also delves into accelerated assessment in Europe and its major public health interest criteria. Our team utilizes the emerging concept of rolling review and its potential benefits, along with the UK's Innovative Licensing and Access Pathway (ILAP), offering regulatory collaboration and rolling reviews. The global collaboration initiatives, including Project Orbis and international recognition frameworks, demonstrate the UK's commitment to expedited access.

Experts in Expedited Product Approval in Europe

Beyond regulatory approval, ProPharma emphasizes the significance of market access strategies and Health Technology Assessments (HTA). We advocate for early consideration of expedited pathways and tailored strategies to maximize program benefits. Our experienced consultants offer guidance and support for our clients, ensuring seamless interactions with regulatory agencies.

ProPharma is a trusted partner for clients seeking to navigate the complex regulatory landscape in Europe. Our expertise encompasses a wide range of expedited programs and market access strategies, enabling clients to efficiently bring innovative therapies to patients. With a focus on collaboration, efficiency, and expertise, ProPharma is the global regulatory partner to facilitate success in the pharmaceutical market.

Clinical Trial Applications (CTA) including GMO and IVDR

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Clinical Trial Applications (CTA) including GMO and IVDR

Navigating the intricate landscape of clinical trial submissions in Europe demands expert touch; we know this because we’ve done it over and over again.

Clinical Trial Application (CTA) procedures in the UK and EU have undergone significant transformations. The harmonization of CTA procedures across these regions has streamlined the process, allowing for a single submission that covers both competent authorities and ethics committees. At ProPharma, we've been at the forefront of navigating these changes and ensuring our clients' success.

Our experienced team actively participated in pilot programs leading up to the introduction of the UK Combined Review Service and the EU Clinical Trial Information Systems. Now, with the EU Clinical Trial Regulation in full effect, ProPharma continues to stand as a reliable partner, guiding clients through this transition phase. In 2023, we proudly achieved numerous initial clinical trial application approvals for our clients and continue to support additional initial applications through to success.

But our commitment doesn't stop there. We also excel in supporting Additional Member States procedures, managing Substantial and Non-Substantial Modifications, and facilitating Transition applications through CTIS.

With a proven track record that spans clinical trial applications, GMO submissions, and performance study submissions for companion diagnostics and IVDs, we're your trusted partner in achieving regulatory success. European regulatory requirements can be daunting, but our seasoned team possesses the in-depth knowledge and experience to guide you seamlessly through the process. Whether it's the rigorous documentation needed for clinical trial applications, the precision required for GMO submissions, or the specialized expertise necessary for companion diagnostics and IVDs, we've got you covered. At ProPharma, we understand the unique nuances of each submission type and have successfully supported a diverse range of clients across various therapeutic areas. With our comprehensive approach and unwavering commitment to compliance, we ensure that your submissions are not only complete but also optimized for swift approval.

Paediatric Drug Development in Europe

Paediatric Investigation Plans (PIP)

In Europe and the United Kingdom, securing Agency agreement on your paediatric development plans is not just a choice—it's mandatory. This critical step is achieved through the submission of a Paediatric Investigation Plan (PIP), and it's essential that each Agency involved agrees to its terms. A PIP may encompass deferrals, permitting the initiation or completion of studies later once additional data becomes available, or it may include mandated measures, potentially granting a waiver from conducting studies in specific paediatric subsets.

PIP applications, which now require separate submissions for the EU and the UK, should be initiated at the conclusion of Phase 1 clinical studies in adults and submitted to the European Medicines Agency (EMA) and/or the Medicines and Healthcare Products Regulatory Agency (MHRA). Unfortunately, many Applicants tend to overlook or underestimate the significance of these applications, leaving limited time for preparation. The PIP approval process itself can be quite lengthy, taking approximately 9 months or sometimes even longer. Therefore, we strongly advise against delaying this crucial step, as it could jeopardize the timing of your initial Marketing Authorization Application (MAA) submission.

Once a PIP is agreed upon, you are firmly committed to executing what has been outlined in the plan. A rigorous compliance check is a prerequisite before the validation of your MAA, ensuring that every detail aligns precisely with the agreed PIP. This meticulous adherence to timelines and obligations is paramount, as any deviations could hinder the validation of your MAA, even for adult filings. 

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If your product is already on the market, a PIP compliance check becomes necessary to demonstrate continued adherence to the plan before any variations for new indications, pharmaceutical forms, or routes of administration can be considered.

If you find yourself in need of submitting a PIP application and are unsure where to begin, whether to submit to the FDA, EMA, or MHRA first, or if you should submit to all simultaneously, ProPharma is your trusted partner. We specialize in planning paediatric strategies and optimizing submission timelines to ensure a globally agreed-upon approach. Over the past five years, we have supported the preparation of more than 40 PIPs, including those submitted to the European Medicines Agency's Paediatric Committee (PDCO) and the MHRA. Our expertise and commitment to regulatory excellence will guide you through the complex landscape of paediatric development, ensuring your strategy aligns with global standards. Contact us today to take the first step towards a successful paediatric development plan.

Orphan Drug Development

Orphan Drug Designation (ODD) Submissions in Europe

ProPharma is dedicated to assisting clients in their mission to bring critical treatments to patients suffering from rare diseases. Acquiring orphan designation in Europe offers a plethora of incentives to support the development of therapies for these underserved populations, including coveted market exclusivity, reduced fees, and access to invaluable scientific advice.

Our commitment to advancing orphan drug development is evidenced by our track record. On average, we assist with 8-10 orphan drug applications each year, leveraging the expertise of our diverse team of seasoned professionals. With a profound understanding of the intricate EU regulatory landscape and the specific requirements for orphan drug designation, we have successfully guided clients through the process. Our portfolio includes diverse rare diseases and spans various product types, encompassing small molecules, biologics, gene therapies, and cell therapies.

Our support extends beyond securing the initial orphan designation. We provide comprehensive assistance with the annual reporting obligations that follow designation, ensuring our clients remain in compliance with regulatory requirements throughout the journey to market authorization.

If you are developing a potential orphan drug, ProPharma is your trusted partner to navigate the EU orphan drug designation process. With our expertise and unwavering dedication, we increase your chances of success in delivering life-changing treatments to those in need. We can accelerate your orphan drug development journey.

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Marketing Authorisation Applications (MAA) in Europe

A well-crafted regulatory strategy is the compass that guides you through the intricate journey towards Market Authorisation (MA) approval. ProPharma understands the significance of this strategy and provides a comprehensive roadmap that delineates the steps, timelines, and key milestones required to navigate the complex regulatory landscape successfully. Whether you're pursuing a standard, conditional, exceptional MA, or aspire for an accelerated assessment, these strategic elements are carefully considered.

The pre-submission phase plays a pivotal role in preparing for a European centralized, decentralized, or national MAA. This preparation can commence as early as 18 months before the scheduled MAA submission date. The intricacies involved are multifaceted and vary depending on the procedure, encompassing eligibility assessments, legal entity considerations, enterprise status evaluations, European Medicines Agency (EMA) systems setup and access, orphan maintenance, paediatric compliance, brand name review, prior scientific advice/protocol assistance, risk management plans, environmental risk assessments, supply chain setup, Qualified Person (QP) Pharmacovigilance, and QP + license to import/batch release, among numerous others. In the case of a centralized MAA submission, multiple interactions may occur, including pre-submission meetings with EMA delegates and discussions with the appointed (Co)Rapporteur and teams. All of these activities require meticulous planning, thorough preparation, and precise execution. Parallel discussions may further complicate matters, particularly in the context of conditional approval or accelerated assessment. ProPharma's Regulatory Sciences Team stands ready to support, coordinate, organize, and lead all pre-submission phase activities, ensuring a seamless process.

During the assessment procedure, ProPharma's Regulatory Sciences Team offers strategic guidance and can assume full leadership responsibilities, guiding you through the process until national or central approval and beyond. Our collaboration extends to close cooperation with your cross-functional experts, and we work as an extension of your team to develop strategies for responding to the List of Questions or Outstanding Issues. We help your team anticipate challenges, prepare in a timely manner, and formulate high-quality responses. Additionally, we are well-equipped to support more complex submissions, such as those related to extensions, additions, or modifications of therapeutic indications.

ProPharma has a proven track record of successfully supporting clients during pre-submission and assessment procedures across a wide range of therapeutic areas, including generics, biosimilars, biotech, and cell & gene therapy (ATMPs) products, having supported over 25 marketing authorisation applications, including the successful approvals for the first gene-therapy medicine in the EU and the first histology-independent treatment for solid tumours in the EU. Our Regulatory Sciences Team comprises a mix of ex-regulators and seasoned industry professionals, and for every project, an experienced Project Lead (Single Point of Contact) is assigned to ensure seamless communication and coordination.

With ProPharma as your regulatory partner, you can navigate the intricate journey to Market Authorization with confidence, knowing that you have a team of experts dedicated to your success. Contact us today to embark on a path to regulatory excellence.

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Ready to obtain regulatory approval in Europe? 

ProPharma's team of expert European regulatory affairs consultants can support your regulatory submission and application needs. Learn how our substantial depth and breadth of scientific and regulatory expertise uniquely positions us to help your product succeed.

Why ProPharma?

Scientific Focus Paired with Regulatory Expertise

Our team of European regulatory consultants is comprised of experts who are scientists first and foremost. Coupled with our extensive regulatory...

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Scientific Focus Paired with Regulatory Expertise

Our team of European regulatory consultants is comprised of experts who are scientists first and foremost. Coupled with our extensive regulatory experience, this has enabled us to achieve a track record of success with the regulatory agencies. We will work with your team to develop approvable submissions by preparing applications in the scientific language spoken by the regulatory agencies reviewing them.

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Track Record of Success

We have been helping companies achieve successful interactions with regulatory authorities across the globe for more than 40 years. During this time, we have built...

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Track Record of Success

We have been helping companies achieve successful interactions with regulatory authorities across the globe for more than 40 years. During this time, we have built relationships with the regulators and established ProPharma as the world's leading regulatory consultancy. Our unique approach is how we have been able to achieve a higher rate of successful regulatory interactions than anyone else over the last 40 years - our track record speaks for itself.

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Global Reach with Local Expertise

Our capabilities are global. but we are not ignorant to the fact that each individual country has intricacies unique to their regulatory agency. This can make it...

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Global Reach with Local Expertise

Our capabilities are global. but we are not ignorant to the fact that each individual country has intricacies unique to their regulatory agency. This can make it challenging to obtain approval in multiple locations. To overcome this hurdle, ProPharma's team of experts are dispersed throughout all of Europe, each possessing the necessary knowledge pertaining to their local country.  This allows us to work with you achieve your goal of getting your product approved globally without compromising the local expertise needed to accomplish it.

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European Regulatory Submission Experts

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Lucy Radley

Senior Vice President
European Regulatory Development

Elizabeth Soames

Elizabeth Soames

Nonclinical Expert

Paula van Hennik

Paula van Hennik

Clinical Expert
ex-CHMP/EMA

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Rhydian Howells

CMC Expert
Biologics and ATMPs

Bertine-Vorstenbosch

Bertine Vorstenbosch

CMC Expert
Small Molecules

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Frank de Vries

Regulatory Strategy Expert

Jens van Wijngaarden

Jens van Wijngaarden

Regulatory Strategy Expert
ex-MEB

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Louisa Vangsted-Rees

CTA Submissions Expert

Sarah-Bell

Sarah Bell

Paediatric Investigation Plan Expert

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