Advancing your goals
Our market access team is dedicated to assisting our customers in maintaining high-quality delivered with a keen eye for regulatory compliance while bringing products to market. With our demonstrated experience in major market sectors, we provide customers with tailored strategies for each project they undertake with us.
Start a conversation
We’re always open for a conversation regarding the possible strategies that can benefit your path toward treating patients throughout the EU. Below you’ll find our most commonly requested services for drug products and Medical Devices.
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Formulating full strategies to bring your product to market
Documentation GAP Analysis
By analyzing the quality of your dosssier for Medical Devices and Drug Products and anticipating authority expectations, we help you adapt your existing dossier to your desired, expected outcomes.
Cost-Effectiveness & Budget Impact
Our cost-effectiveness studies determine whether your innovative therapy adds value in comparison to an already available intervention and whether the high-value intervention is ‘affordable.’
Authorization Procedure Support
We provide complete, hands-on support during marketing authorisation prodedures and help you enter all European Union (EU) Member States through the EMA or Notified Bodies
Value Dossier Preparation
We create and include value statements and supporting evidence into your Value Dossier to demonstrate your product’s value to a diverse set of stakeholders.
Early Dialogue Preparation
ISHEO’s experts help you engage in early discussion with payers and health technology assessment (HTA) authorities to ensure that a proposed trial design fulfills modern criteria.
Value Proposition Creation
We generate successful value propositions by fostering a collaborative and aligned culture, clearly defining roles and duties, and developing a risk-mitigating roadmap.
Drug Products specific
Eligibility Request Submission
We help submit an eligibility request using the specific form and a reason to find out if a product can be considered under the centralized approach.
Notification of Intent to Submit
We employ industry best practices to increase the predictability of your submissions and ensure compliance with EMA deadlines.
Medical Device specific
Technical File Preparation
We help Medical Device manufacturers prepare technical documentation or a design dossier to complete the conformity assessment performed by the notified body.
Laboratory & Clinical Test Selection
Companion diagnostics are used to identify eligible patients and require selecting appropriate test methods. We help you navigate different approaches to fund companion diagnostics within the EU.
Clinical Evaluation Report
Isheo’s specialists can write Clinical Evaluation Report (CER) documents to conclude the clinical evaluation of your medical device and pave the way for market authorization.
Advantages of working with ISHEO
We engage and actively collaborate with clinicians and health practitioners, as well as with businesses, investors, and entrepreneurs, in order to stimulate healthcare innovation. We have a track record of successful collaboration with people from diverse origins and cultures and utilizing entrepreneurial energy to empower one another.
Project Management – ISHEO follows the Project Cycle Management (PCM) approach and design all phases and tasks to ensure your strategy addresses every aspect in the complex environment,
Full Service – An end-to-end process through the engagement of a competent team that is experienced with national market access strategies and is capable of adapting it to regionalized approaches.
Strong Alignment – Besides adhering to your strategic goals, targets and timelines, we consistently manage a broad network of investigators and KOLs to guarantee all stakeholders are informed and aligned.
“Ensure Access for Patients across the EU. “
Ask Us Anything
Please feel free to contact us. We’re always glad to offer you our support, discuss how to generate new evidences and disseminate results of modern-day advances in medical science.
We will be glad to listen to you, and we will turn back to you with a tailored strategy, a detailed plan of activities, and a mindset to help you advance your goals.