European Lifecycle Management

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

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

Hand writing on clipboard with a pen

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.

Two business casual professionals discussing around a Tablet device

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 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

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.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

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
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.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

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