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Entering the EU market
Anticipate the end of the road to advance your innovative product development in Europe
KEY FIGURES
1st
To obtain an MAA in a tissue engineered product in Europe
100+
Health authority interactions per year
>90%
Consultants with a PhD/M.Sc/Pharm D.
SOLUTIONS
VCLS provides integrated solutions all along the development journey
Preclinical Development
Early-stage clinical development
Late-stage clinical development
Registration & Post-approval
- Regulatory roadmap and strategic positioning for European market specificities
- Scientific Advice with the EMA and/or national competent authorities
- Nonclinical development and study design
- Author the IMPD for Clinical Trial Application (CAT)
- Analytical method development and validation to support future clinical development.
- Early-phase study design
- Preparation and submission of the Clinical Trial Application (CTA) PRIME, Orphan Drug Designation (ODD), Pediatric Investigation Plan (PIP)
- Clinical/nonclinical plans to secure safety & efficacy evidence generation
- CMC development plan to ensure First-In-Human (FIH)
- Clinical trial site selection, patient recruitment, trial monitoring, as well as data management and biostatistics
- Implementation of EMA-compliant safety reporting systems, including EudraVigilance registration
- Market landscape analysis and positioning
- Prepare the submission of MAA
- Conduct of pre-submission meetings and other regulatory and payer interactions
- Author Module 3 (CMC) of the MAA, including analytical method validation and comparability data
- Ensure CMC support during pivotal trial and for registration readiness
- Clinical trial management
- Development of Risk Management Plans (RMP)
- Set up strategy related to Joint Committee assessment during registration (PICO), including costs associated with disease management, value dossier & core economic models, and pricing strategy
- Review and submission of the MAA
- Lifecycle management of the MAA, including variations and renewals
- Ongoing manufacturing and supply chain support to ensure compliance with EMA and CGMP standards
- Full operation of a PV system, including EudraVigilance data management and signal detection
- Early Access Program (EAP)
- Market access and confirmation/solidification of the strategy related to Joint Committee assessment during registration (PICO)
- National reimbursement dossier preparation
- Real-world evidence (RWE) generation to support payer discussions and future regulatory submissions
Strong medical, scientific and regulatory knowledge and know-how
Seasoned in-house multidisciplinary regulatory, clinical, nonclinical, CMC, market access, and patient engagement teams with hands-on experience gained during tenures with regulatory agencies.
Evidence generation: driving patient access
We excel in generating robust, integrated evidence packages that meet the stringent demands of regulators, payers, and healthcare providers. With deep regulatory insights, real-world evidence expertise, and a focus on market access alignment, we turn your data into a compelling narrative that accelerates approval and ensures patient access.
FAQs
Can I convert my IND into the EMA’s CTR?
Not exactly. The US FDA’s IND and the EU CTR support the same purpose: authorizing clinical trials with medicinal products. However, their technical formats are significantly different.
The US IND is an authorization to import non-licensed drugs into the US for human investigation. Once the IND is “opened,” it creates a “virtual space” for clinical investigation. On the other hand, the EU clinical trials authorisation (CTA) is identified by a unique EudraCT reference, “coupling” an IMP with a clinical trial (e.g., a new CT with same IMP would warrant a new CTA submission/approval).
While the IND is published to the FDA under eCTD format, a clinical trial application (CTA) in the EU under the CTR must be processed through the online platform called Clinical Trials Information System (CTIS). This format mostly relies on data/information entered into the system’s forms, as well as a number of documents, generally in PDF format.
With that being said, their content can be similar to a certain extent. For example, the study protocol, compliant with ICH standards and designed with an international purpose, can be the same. Also, quality data (Module 3) of the IND can be converted into the European Investigational Medicinal Product Dossier (IMPD).
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What is the most relevant regulatory/HTA body to engage with for bringing my HealthTech product to the market?
EU regulatory/HTA stakeholders may seem like a complex ecosystem and a “one size-fits all” approach may not apply.
Be reassured that within your partnership with VCLS, our experts will enable you to:
- identify the right stakeholder,
- make them your best advocate among the rest of the stakeholder community, and
- foster the best environment to reach and stay on the market.
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Related Glossary
European Medicines Agency (EMA)
CE-Marking Technical File
Health Technology Assessment
Orphan Drug Designation (ODD)
Scientific Advice
Priority Medicines (PRIME)
EU Joint Clinical Assessment (JCA)
Questions? Get the answers from our expert team
No two product development paths are the same. Talk to our experts about your development challenges and we will provide you actionable recommendations.