European Regulatory Development

Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes

Colorized half circle.
Regulatory Sciences Flywheel

The World's Leading Regulatory Partner in Europe

At ProPharma, we are your trusted partner on the path to pharmaceutical success in Europe. With a team of experts boasting deep-rooted knowledge in regulatory affairs, including former EU Regulatory Agency and ex-CHMP staff, alongside seasoned industry professionals with decades of experience, we offer the comprehensive support and strategic direction needed to move your product from one regulatory hurdle to the next.

Explore Our European Regulatory Development Services

We share your commitment to getting innovative products into the hands of patients who need them most.

 

Expert European Regulatory Affairs Consultants

Our focus is clear: to support the delivery of effective solutions to all patients, ensuring that everyone has access to improved healthcare options. From the earliest stages of nonclinical testing to navigating the complexities of clinical trials and marketing authorization applications, we are here to guide you every step of the way. Having successfully supported hundreds of development programs spanning various therapeutic areas and product types, including small molecules, biologics, and advanced therapies, our team is poised to deliver a holistic, and tailored service of unrivaled quality, designed to make your vision a reality.

European Regulatory Strategy & Gap Analysis

Every regulatory submission has a lot of moving parts, each one interconnected with the others. Due to the number of regulatory agencies throughout Europe and the associated approval pathways that can be selected for your product, these intricacies are further amplified throughout the European region. Having a clearly defined and well thought through European regulatory strategy is a crucial component of your product’s success.

Whether you’re seeking approval on a national, European, or global level, our expert European regulatory strategy consultants will work with you to develop an appropriate regulatory strategy and gap analysis for your drug, biologic, or medical device. We take a holistic approach, beginning with early product development and spanning through post-authorisation product maintenance or anywhere in between.

Strategic thinking transcends conventional "regulatory guidance" encompassing a holistic approach that aligns various functions within an organization to establish mutually formulated and embraced goals. At ProPharma, we understand that a successful regulatory strategy extends beyond the surface, covering the entire lifecycle of a development program. We take a forward-looking approach, aiming to identify changes, assess risks, anticipate roadblocks, and surmount hurdles while advising on pertinent mitigations.

Hand writing on paper

Our approach is not only global but also adaptable to specific regional or subregional needs, allowing for nuanced focus on sub-strategies, such as pediatric and orphan development, and the ability to address single questions, review clinical development planning, and provide gap analyses.

Regulatory strategy begins at the earliest stages of development, treating it as a dynamic, living entity that continuously adapts to shepherd the product through its lifecycle. A well-designed regulatory strategy is an upfront investment that pays dividends in time and resources saved, while also providing clear direction for the cross-functional development team.

One of the key components of a comprehensive regulatory strategy is the Target Product Profile (TPP), an integral element grounded in jointly developed goals, expectations, and aspirations. The TPP encapsulates label anticipations and is informed by a landscape analysis encompassing competitors, precedents, and guidelines review. This analysis aids in understanding the Probability of Regulatory Success (PRS) and Technical Success (PTS). The TPP serves as a framework for internal discussions and is invaluable for external engagements with global regulatory agencies. Furthermore, the strategy document aligned with the TPP provides critical insights, including submission to approval planning and targets for nonclinical, quality, efficacy, and safety aspects.

ProPharma brings substantial expertise to the table when partnering with clients to develop and realize their regulatory strategies. We have supported over 50 clients in crafting tailored regulatory strategies for complex development programs spanning various therapeutic areas and product types. Our profound knowledge across nonclinical, clinical, and CMC domains ensures meticulous consideration of potential hurdles and their effective mitigations. With ProPharma as your partner, you can confidently navigate the optimal path forward for the development of your product in Europe, secure in the knowledge that your regulatory strategy is in expert hands.

Scientific Advice

Organizations seeking Scientific Advice can navigate various routes, including engagement with the Committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) or National Competent Authorities (NCAs), such as the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). Furthermore, recent introductions like joint EMA/FDA advice, parallel consultations with regulators and health technology assessment bodies, and simultaneous national scientific advice initiatives, offer additional options.

Medical professionals business professionals working at a conference table

With a number of pathways that can be taken, having a clear plan that supports your overall regulatory strategy is critical. At ProPharma, our team of experts possess a deep expertise in European Scientific Advice procedures and initiatives across the entire European Economic Area (EEA). This uniquely positions our team of regulatory affairs consultants to help you advance your drug development efforts in the most efficient and effective manner possible.

European Regulatory Submissions and Applications

Pre-authorisation regulatory deliverables are a critical part of the European regulatory approval process. Our team of expert regulatory affairs consultants can help you develop and submit the best possible application for submission to the EMA or NCAs, working with you to successfully reach the next regulatory milestone.

Our team of expert European regulatory consultants support:

  • Expedited Pathways
  • Clinical Trial Applications (CTA)
  • Paediatric Investigation Plans (PIP)
  • Orphan Drug Submissions (ODD)
  • Marketing Authorisation Applications (MAA)
  • European Medical Device Regulation (MDR)
  • CE filings
  • Health Technology Assessments (HTAs)

European Nonclinical Drug Development

In the realm of pharmaceutical development, a robust nonclinical package is the cornerstone of success, especially in the early phases and beyond. It's the compass that guides you through regulatory expectations and provides the precise data needed to bolster your clinical development efforts. At ProPharma, we recognize the paramount importance of this phase, and our dedicated team of nonclinical experts collaborate closely with each client to deliver a nonclinical package that not only meets regulatory requirements but also aligns seamlessly with the client's overarching drug development strategy.

Our nonclinical experts are adept at defining the specific requirements for nonclinical studies, meticulously identifying and mitigating potential risks, and proactively addressing any gaps or development issues. With this holistic approach, we ensure that your nonclinical package is not only compliant, but of the highest quality, providing the foundation upon which successful clinical development is built.

Moreover, ProPharma operates with a flexible mindset, recognizing that each client's needs and circumstances are unique. We collaborate within our nonclinical team and with our counterparts in other critical areas, including CMC and clinical development, to ensure a cohesive strategy that harmoniously integrates nonclinical data with other facets of drug development. We are unwavering in our commitment to closely monitor the ever-evolving regulatory landscape, ensuring that the pathway to clinical development is well-mapped and seamless.

Woman in lab injecting test tubes

When you partner with ProPharma, you can rest assured that your nonclinical package will not only meet regulatory expectations but will be a powerful asset in driving your drug development journey forward. Our dedication to quality, adaptability, and regulatory expertise ensures that your path to clinical development is marked by success and confidence at every step.

European Clinical Development

Clinical development failures can result from a myriad of factors, but often, they stem from inadequate planning and an incomplete grasp of critical product development principles. At ProPharma, we understand the importance of mitigating these risks, and we collaborate closely with each client to craft cutting-edge clinical trial designs. Our approach is rooted in a deep understanding of the clinical context, utilization of available (non)clinical data, deep understanding of European regulatory guidelines and precedents, and meticulous consideration of statistical aspects that align with our clients' overarching drug development strategies.

Two women technicians using a laptop in a laboratory.

Our strength lies in our in-house, global, and multidisciplinary expertise, which can be tailored to meet the specific needs of our clients. We maintain a keen awareness of the diverse regulatory requirements across different jurisdictions, ensuring that our clients receive comprehensive, well-informed, and actionable clinical development plans.

In this flexible and collaborative ecosystem, ProPharma is committed to delivering detailed and feasible clinical development strategies that are not only well-founded but also adhere to deadlines. With ProPharma by your side, you can trust in our ability to navigate the complex landscape of clinical development, setting the stage for your success.

European Regulatory CMC Plan Development

Chemistry, Manufacturing, and Controls (CMC) is a critical component and a ‘first step’ in the creation of a development strategy for an asset. Without a solid development plan for the investigational product, regulatory agencies will not be able to adequately assess the safety and efficacy for approval of clinical trials and later approvals.

We understand that companies need to carefully balance the costs of early investment in CMC-related activities, when cash burn needs to be more tightly controlled, versus early under-investment in CMC leading to significant extra costs and critical delays later in development. It is especially important for companies developing treatments for indications with high unmet need where despite expedited pathways offering accelerated approvals based on early clinical data, the CMC package must be complete at the time of filing.

Regulatory Science Experts

lucy radley headshot

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

Headshot placeholder.

Rhydian Howells

CMC Expert
Biologics and ATMPs

Bertine-Vorstenbosch

Bertine Vorstenbosch

CMC Expert
Small Molecules

Headshot placeholder.

Frank de Vries

Regulatory Strategy Expert

Jens van Wijngaarden

Jens van Wijngaarden

Regulatory Strategy Expert
ex-MEB

Headshot placeholder.

Louisa Vangsted-Rees

CTA Submissions Expert

Sarah-Bell

Sarah Bell

Paediatric Investigation Plan Expert

Gradient Image

Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.

News & Insights

What is a LIMS, and How Do I Know if I Need One?

June 20, 2024

What is a LIMS, and How Do I Know if I Need One?

Learn about Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELNs), and how to determine if your lab needs one.

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
What is a LIMS, and How Do I Know if I Need One?

June 20, 2024

What is a LIMS, and How Do I Know if I Need One?

Learn about Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELNs), and how to determine if your lab needs one.

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow