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Regulatory

We support our clients with building a regulatory strategy to successfully accompany their product through its entire lifecycle, from launch to patent expiry.

Obtaining market authorisation is the first major hurdle towards Market Access and a successful product launch. However, the regulatory environment is sometimes perceived as impenetrable, and the procedures leading to product approval as cumbersome. This represents a challenge, not only to companies located outside the EU, but also for companies with a limited in-house infrastructure and regulatory experience.

We realise that it is important to work with a partner you trust, who is reliable and delivers high-quality work even under tight timelines. We have a proven track-record of successfully guiding (bio)pharmaceutical companies through the regulatory jungle, irrespective of the therapeutic area.

Understanding that market access is a continuous process, which includes market authorisation, label extensions and renewals, we collaborate with a unique network of clinical and regulatory experts who will guide you through the entire regulatory lifecycle.

Contrary to the traditional service providers, the team at Executive Insight can provide you with an integrated Market Access strategy, which will include advice on regulatory submissions, health technology assessment and reimbursement.


We offer a complete spectrum of regulatory services:

  • Regulatory Strategy: Defining the optimal regulatory approach in alignment with the business strategy and market potential of your product is a key step prior to product launch. We help our clients select the most suitable registration procedure, both in terms of type, scope and desired timelines.
     
  • Regulatory Intelligence: To keep abreast of all new regulations and guidance documents and to truly understand how they should be implemented, we will identify the information most relevant to your product and apply it to your regulatory strategy. Mapping the stakeholders who are likely to be involved in the regulatory process (authorities, committees, assessors) can provide you with a deeper understanding of the chances of success for approval of your product.
     
  • Regulatory / Scientific Due Diligence: Obtaining an independent second opinion on the value of your scientific data is paramount for a successful approval and can pre-empt potential hurdles during the filing procedure. Our scientific experts will be able to critically review your clinical data and perform an in-depth gap analysis. We also assist clients with products in early clinical development to help establish a clinical study plan. We firmly believe in the integration of real-world evidence into the clinical study plan and provide advice on the specific requirements of such studies, in collaboration with our partners from PHMR Associates.
     
  • Regulatory Communication: Flawless communication with the regulatory authorities is as important as a robust dataset. We help you to prepare meetings with the relevant authorities (advice meetings, pre-submission meetings), including the preparation of high-quality meeting packages. Our network of experienced medical writers can support you with the technical writing.  Assessment of agency decisions and strategic guidance for response is an additional asset we offer.

For more information or to discuss in person, please contact our team:


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