Unlocking the European Market for Your
Rare Disorders Assets

Unveiling Your Path to Success in Rare Disease Development

Our infographic visualizes the comprehensive spectrum of services we offer to support your rare disease asset development journey, from pre-clinical research to successful commercialization.

Partner with a Team of Seasoned Experts

Benefit from the guidance of pioneering scientists, seasoned advisors, and industry veterans who have a proven track record of success in rare disease development.

Leaders in Translational Science : Experts who bridge the gap between research and real-world application, accelerating breakthroughs for patients.

Policy and Regulatory Advisors: Navigators who understand the complex regulatory landscape and guide you through the approval process.

C-suite Executives: Former leaders from the largest, rare disease pharmaceutical and biotechnology companies, bringing unparalleled strategic insights.

Experienced Legal Counsel: Experts specializing in the life sciences industry, ensuring your journey is compliant and secure.

Partner Rare empowers you with

 Strategic advisory and consulting 

           Gain expert guidance at any stage of development, tailored to address your specific challenges and goals.

 

  Partner Forward Accelerator Program

           Receive comprehensive mentorship and support designed to propel start-ups and emerging companies through the entire                                         development and commercialization process.

 

           Whether you require specialized advice or a comprehensive support system, Partner Rare is here to equip you for success.

Navigate the complexities of the European rare disorders market with our unmatched expertise. We offer a comprehensive suite of services tailored to help you bring your rare disorder assets to market effectively and efficiently.

Our team of seasoned industry leaders provides bespoke consultancy services, including:

 

We provide strategic guidance to help develop an accelerated market entry strategy and maximize the commercial potential of your rare disorder assets. Our seasoned team provides expert advice on a variety of specialist areas, ensuring your product’s successful launch and sustained growth.

 

We conduct comprehensive HEOR analyses and provide expert advice on pricing and reimbursement strategies to optimize market access. Our market access team are specialist in rare disorders’ European market asset entry and work in strategic partnership with our regulatory experts.

 

We develop and execute tailored marketing campaigns to create a strong, compliant brand identity for your product. Our marketing consultants have supported blue-chip organisations and are well-informed on approaches of both pre and post MA marketing approaches.

 

Partner Rare’s legal team are experts in all facets of pharmaceutical and biotechnology law. Our veteran legal team will ensure the compliance of your asset’s commercialisation into Europe. We also can provide strategic advisory and consulting, and management all partnering agreements to ensure speed and accuracy, whilst working in sync with our financial team to ensure overall project management excellence.

 

Navigate the Complexities of European Market Entry for Rare Disorder Therapeutics

Embark on a successful European rare disorder therapeutics journey with our expert guidance. Our integrated legal and consulting services provide seamless support for all aspects of your market entry, from strategic planning to operational excellence.

 

Comprehensive Legal Expertise

Unmatched Legal Counsel: Receive comprehensive legal counsel for all phases of product development, regulatory compliance, market access strategies, intellectual property protection, licensing, commercial agreements, and technical agreements.

Quality Agreements Mastery: Gain expert guidance on drafting, negotiating, and managing quality agreements, ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

M&A Expertise: Secure strategic advice and legal support for mergers and acquisitions (M&A) transactions, safeguarding your intellectual property and business interests.

 

Unparalleled Operational Support

Business Entity Establishment and Management: Receive comprehensive support for establishing and managing your European business entity, including legal, regulatory, and tax considerations

Personnel Recruitment and HR Solutions: Leverage our expertise in recruiting, onboarding, and managing your European workforce, ensuring compliance with local employment laws and regulations.

Pharmacovigilance and Post-Market Surveillance: Access comprehensive pharmacovigilance and post-market surveillance services, ensuring patient safety and regulatory compliance.

Accounting and Tax Compliance Expertise: Gain expert guidance on accounting and tax compliance matters, minimizing financial risks and maximizing tax efficiency.

 

Partner with the Experts

Our team of seasoned professionals ensures your smooth and compliant entry into the European rare disorder therapeutics market. Contact us today to unlock the potential of your innovative therapies.

 

Our extensive industry experience enables us to connect you with potential partners for licensing, co-development, and commercialization opportunities. We leverage our extensive network to identify and connect you with potential partners, enabling you to secure licensing deals and expand your market reach.

Combining decades of regulatory experience; Partner Rare’s expert team provides strategic advisory and consulting on asset regulatory requirements entry into Europe. From IMPDs to ATMP registrations, we can ensure compliance with all regulatory requirements throughout the commercialization process.

Our team of regulatory rare disease experts are here to guide you through every step of the European drug development process, from crafting comprehensive development plans to securing Orphan Drug Designation (ODD). We’ll help you assess the suitability of applying for innovative pathways like the Innovation Task Force (ITF) and PRIME, prepare robust applications, and navigate scientific advice procedures with the EMA and national authorities. Our team will also ensure compliance with obligations such as submitting a paediatric investigation plan (PIP) and leverage any additional opportunities for dialogue with regulatory bodies.

With a proven track record in European regulatory affairs, we’re committed to facilitating your journey towards successful market authorization in the EU.

 

We build awareness and support for your product through strategic engagement with key stakeholders, including HCPs and patient groups.

 

We provide expert financial management services to optimize budgeting, forecasting, and funding acquisition.

 

We ensure your product commercialization activities are completed on time and within budget, mitigating risks and addressing potential issues.

 

We assist you in navigating the intricate world of rare disorder financing, helping you secure funding to accelerate your development and commercialization efforts. By connecting you with potential investors and financing partners, we can support your growth and innovation, and help to bring new therapies to rare disorders’ patients across Europe.

Introducing

Accelerate Your Rare Disorder Innovation to Market Success with Our Bespoke Accelerator Program

In the intricate realm of rare disorder solutions, Partner Forward, our Bespoke Accelerator Program, provides you with a meticulously crafted program empowering you to navigate the complexities of rare disorder asset commercialization.

Partner with our team of industry luminaries, each possessing unparalleled expertise in the intricacies of rare disorder development and commercialization. Our team’s collective experience will guide you through every stage of your journey, ensuring that your assets are optimized, primed for regulatory clearance, and strategically positioned for European market entry.

Through our curated connections, you will gain access to the financial resources necessary to fuel your growth and bring your transformative innovations to life. Leverage our network to forge strategic partnerships that expand your market presence and amplify your impact. Our team will connect you with potential collaborators, enabling you to establish a robust network of allies across the European rare disorder landscape.

As you approach market launch, our expertise in regulatory affairs and market entry strategies will provide you with the efficiencies for commercialization. Our team of legal and financing experts will handle all formalities ensuring your journey is compliant. With our expertise, you can focus on what matters most: bringing your life-changing rare disorder solutions to market and making a positive impact on the lives of patients across Europe.

Our Bespoke Accelerator Program is not merely a program; it is a catalyst for transforming innovative ideas into life-changing rare disorder solutions.

Contact us today to learn more about Partner Forward, and how you can witness the transformation of your rare disorder assets in helping patients across Europe.

Ready to work
with us?

Whether you require a single consultation or long-term advisory across a diverse range of areas,
our industry-leading team is committed
to exceeding your expectations.

Ready to work
with us?

Whether you require a single consultation or long-term advisory across a diverse range of areas,
our industry-leading team is committed
to exceeding your expectations.