European Regulatory Development

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.

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.

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.

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.

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.