European Lifecycle Management

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

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Regulatory Sciences Flywheel

The World's Leading Regulatory Partner in Europe

Unlock the full potential of your product. Post-Approval, ProPharma’s team of expert regulatory consultants ensures compliance with regulatory requirements across Europe and maximizes your product’s impact. At ProPharma, we recognize that every organization has unique regulatory needs. Whether you’re a global corporation or a local player, our flexible approach ensures that you receive the right level of support. ProPharma is more than a service provider; we’re your strategic partner in regulatory excellence. 

Explore Our European Regulatory Lifecycle Management Services

We share your commitment to keeping innovative products on the market and in the hands of patients who need them most.

 

Regulatory Product Launch

Optimizing the value of a medicine from a regulatory perspective is a multifaceted endeavor, which necessitates meticulous planning. Each country or region has unique regulatory requirements, healthcare systems, and market dynamics. In this context, a robust post-approval launch strategy plays a pivotal role in ensuring a successful post-approval product launch. Local regulatory launch plans are essential for navigating country-specific intricacies, ensuring compliance, and optimizing market access.

Our Regulatory Product Launch Consulting Support Includes: 

  • Project management; multi-country
  • Product launch checklists
  • Review of artwork for printing
  • Registration in local regulatory databases
  • Publication of product information in local catalogue texts
  • Registration with local serialization verification organizations
  • Advice on specific local country regulatory requirements

European Regulatory Lifecycle Management

After your initial application has received marketing approval from the regulators, you need to remain compliant with all regulatory requirements needed to keep your product on the market. A strategic approach to lifecycle management is necessary to maximize the potential of your product.

ProPharma serves as a true extension of your team, helping you with every aspect of regulatory lifecycle management activities. Our team of regulatory affairs consultants is made up of scientists who possess a deep understanding of the intricacies of regulatory lifecycle management across all phases of the product lifecycle.

We have extensive knowledge and experience in project management as well as submission and procedural management and can partner with you at any point in the process to provide strategic input and end-to-end planning of submission activities, e.g. analyze and prepare documentation, compile the submission, publish, and submit the application and correspond with relevant health authorities.

Hands holding pens working over layers of papers and post it notes

Our European Regulatory Lifecycle Management Consulting Services Include: 

  • GAP analysis and submission strategy
  • Dossier compilation
  • Regulatory advice, including pre-submission meetings
  • All types of regulatory submission, e.g. variations (e.g., labelling, referrals), line extensions, renewals
  • Publishing (eCTD)
  • MAH-transfers
  • CMC support, including strategic advice, Module 3 updates, and technology transfers
  • Health Authority liaison services (communication)
  • Support for post-authorization commitments
  • Management of catalogue texts
  • Management of local regulatory databases
  • Product information (PI) updates/translations
  • Artwork reviews
  • Readability testing

Regulatory Project Management

In the dynamic landscape of pharmaceuticals, regulatory compliance is paramount. From drug development to market approval and commercialization, every step requires meticulous planning, coordination, and adherence to global standards. This is where Regulatory Project Management steps in as a critical function.

 

The Role of a Regulatory Project Manager in the Pharmaceutical Product Lifecycle

Confident worker woman looking at camera

Regulatory pathways vary across countries and regions. Regulatory project managers must be dynamic individuals, often serving as the team leader, acting as the “central hub” connecting the internal teams and external stakeholders as they work to eliminate potential hurdles across functional areas. A good regulatory project manager is a detailed planner by nature, ensuring seamless continuity throughout the product’s lifecycle.

At ProPharma, our team of regulatory project management consultants are well versed in the complexities of the global regulatory landscape, with extensive experience working with our clients to successfully navigate the maze of global regulatory requirements.

Our Regulatory Project Management Consulting Support Includes:

  • Expert team of Regulatory Project Management consultants with extensive experience combining scientific, regulatory, and business knowledge to ensure products that are developed, manufactured, or distributed meet regulators’ expectations at regional, national, and local levels
  • RPM coordination of all European Regulatory activities (Regulatory submission strategy, multi-country Product Launch, Product Lifecycle Management, Regulatory Intelligence, and Promotional Materials Review)
  • End-to-end planning, coordination, and execution of regulatory procedures and submissions
  • Delivery through proactive and open communication, effective project planning, stakeholder management, leading cross-functional teams, communication planning, risk mitigation, and issues resolution

Regulatory Intelligence

In the ever-changing regulatory landscape, staying informed of applicable regulatory requirements is crucial. Regulatory Intelligence involves systematically gathering and analyzing publicly available information related to regulations. Monitoring regulatory changes demands seasoned expertise and our team brings years of experience, providing you with actionable insights that empower your compliance efforts.

Our Regulatory Intelligence Consulting Services Include:

  • Global and local Regulatory Intelligence support
  • Strategic advice on national legislation and specific requirements
  • Monitoring evolving information and responding to changes in the regulatory landscape
  • Identifying, integrating, and analyzing regulatory information
  • Reporting according to customer requirements

Review of Promotional Materials

In the life sciences industry, reviewing promotional materials is not just a formality; it’s a critical step in ensuring compliance, patient safety, and brand reputation. Promotional materials must adhere to strict local regulations and deviations can lead to penalties, product recalls, or legal consequences. Rigorous review ensures that claims are evidence-based and do not misrepresent the product’s benefits or risks. Promotional materials directly impact how healthcare professionals and patients perceive a product. A well-reviewed campaign enhances trust, while errors can tarnish the brand's image.

Our European Promotional Review Consulting Services Include: 

  • Regulatory review of promotional materials in accordance with the respective ethical codes in the local country
  • Creation and update of Abbreviated Product Information (API) texts
  • Support in setting up a routine for local review of promotional materials in the local country
  • Advice on general questions regarding the local ethical codes

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Outsourced Regulatory Affairs Functions

In today’s dynamic business landscape, organizations face increasing regulatory complexities. Navigating global and local regulations demands expertise, resources, and strategic planning. We recognize that each client is unique and adapt our service offering according to our clients’ needs. Outsourcing regulatory functions can be a strategic move to optimize efficiency, enhance compliance, and focus on core business objectives. Whether you’re a multinational corporation or a local player, understanding the benefits and considerations of outsourcing your regulatory affairs obligations is crucial. At ProPharma, we don’t just manage projects; we drive them forward. With our unwavering commitment to oversight, strategic thinking, and client engagement, we’re your trusted partner in achieving regulatory success.

Outsourcing all or part(s) of your regulatory affairs department to ProPharma’s team of Regulatory Sciences experts provides access to a pool of seasoned professionals.

  • Our regulatory consultants understand the intricacies of diverse regulatory frameworks, ensuring accurate submissions, compliance, and timely approvals. Our consultants bring a wealth of experience and up-to-date knowledge of global regulatory standards, ensuring your projects meet all necessary requirements. Our team collaborates with yours to fine-tune strategies, optimize resource allocation, and align with your business goals.
  • We work in close collaboration with our clients to identify business goals, set and refine strategies, address potential challenges, and celebrate milestones.
  • We understand that business needs may change over time and our agility ensures that we pivot when needed. Maintaining an in-house regulatory team can be resource intensive. Outsourcing allows you to allocate your resources more efficiently, reducing overhead costs while maintaining quality. Our team can be scaled up or down based on project needs without the long-term commitment of full-time hires.
  • Navigating international markets requires knowledge of local regulations. ProPharma’s global reach ensures compliance across borders, enabling market expansion without compromising quality.

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Whether you opt to outsource your all or just a portion of your Regulatory Affairs function or prefer an integrated approach where our consultants become part of your team, ProPharma is here to support you. ProPharma provides tailored and seamless solutions according to our clients’ needs.

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.

Regulatory Science Experts

  • Lucy Radley Bio Photo

    Lucy Radley

    Senior Vice President, European Regulatory Development

  • Elizabeth Soames Bio Photo

    Elizabeth Soames

    Group Head, Nonclinical Regulatory Sciences

  • Paula van Hennik Bio Photo

    Paula van Hennik

    Group Head Medical and Regulatory Sciences

  • Rhydian Howells Bio Photo

    Rhydian Howells

    CMC Expert
    Biologics and ATMPs

  • Bertine Vorstenbosh Bio Photo

    Bertine Vorstenbosh

    CMC Expert
    Small Molecules

  • Frank de Vries Bio Photo

    Frank de Vries

    Vice President, Strategy, Regulatory Sciences – Development

    View Bio

  • Jens van Wijngaarden Bio Photo

    Jens van Wijngaarden

    Senior Director, Regulatory Sciences

  • Louisa Vangsted-Rees Bio Photo

    Louisa Vangsted-Rees

    CTA Submissions Expert

  • Sarah Bell Bio Photo

    Sarah Bell

    Paediatric Investigation Plan Expert

Frank has over 30 years of experience in industry in a broad Regulatory Scientific field across all product types and multiple therapeutic areas including (pediatric) rare diseases and leads a team of subject matter experts in Regulatory Sciences to advise, support or lead overall regulatory strategy development and execution.

Frank’s broad and varied experience within the drug development industry includes significant interaction with the European Medicines Agency (EMA) and majority of national regulatory agencies across Europe, Middle East, CIS Region, Africa and to a certain extent LATAM, APAC, Canada, Australia, US. Regulatory interactions include but are not limited to scientific advice/protocol assistance, orphan applications and maintenance, pediatric investigation plans, early interactions, pre-submission meetings with EMA and/or Rapp/Co-Rapp and full marketing authorisation application pre-submission and full procedural support.

Frank has led various due diligence activities for product or portfolio acquisition and supported various Mergers & Acquisitions and served as international expert witness in arbitration court cases. Aside from Regulatory Scientific experience, Frank also held positions in Business Development, In/out-licensing, Commercial, Marketing & Sales, Quality and Pharmacovigilance.

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