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Ienke Brombacher
pharmacist, Director Regulatory affairs

Ienke Brombacher, pharmacist, started as Xendo’s new Director Regulatory Affairs. Ienke was working as Director Regulatory Affairs & Drug Safety at AstraZeneca. In this role she is responsible for Regulatory Affairs, Drug Safety and Medical Information and is part of the European Regulatory Management Team within AstraZeneca. The College ter Beoordeling van Geneesmiddelen (CBG) is Ienke’s previous employer, where she worked between 1997 and 2008 in various roles, lastly as a Head of a Pharmacotherapeutical Group.

Ienke gained commercial experience at Abbott where she worked before she moved to the CBG as Marketing Manager and Market Development Manager. As a Management Team member she was responsible for license and acquisition projects. She is a board member and co-founder of RegNed. RegNed is a Regulatory Affairs-network, hosted by the NVFG (Nederlandse Vereniging voor Farmaceutische Geneeskunde), During her function at AstraZeneca she was also part of the workgroup ‘Pharmaceutical Business’ within Nefarma and takes part on behalf of Nefarma in the CCR- meetings with the CBG.

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We help to navigate the scientific and regulatory requirements and provide high-level RA services in all phases of a product’s life cycle: from early-stage development to marketing authorization and post-approval requirements. We provide a complete range of services needed for the successful preparation, submission, and support of pharmaceutical, biopharmaceutical, and medical device dossiers. We are an experienced partner to facilitate the contact with Health Authorities and Notified Bodies during the development and maintenance phase of your product(s).

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Regulatory Strategy & Intelligence

An overall regulatory strategy is essential for successful drug and medical device development and has the perspective of shortening the time to market. Regulatory intelligence forms the basis for the appropriate strategic considerations and consists of essential components such as choices related to the procedure to follow, the regulatory environment, and legal requirements.

Our regulatory intelligence service can visualize the regulatory landscape associated with the drug development and approval process. We investigate historic decisions of regulatory agencies relevant to your product to anticipate on future decisions. We consider relevant regulations and guidance documents and investigate competitor products for example patents and market exclusivity.

When facing the challenge of developing a medicinal product, you have to consider the pharmaceutical, non-clinical and clinical development. In addition, regulatory requirements need to be implemented in the development process. To do so you need to design a regulatory strategy. Whether your product is an innovative small molecule, a biological or an ATMP, or whether the product is a generic or a biosimilar: Xendo can draw the regulatory landscape for your product and develop a regulatory strategy. Our strategic regulatory support is also relevant in the context of a merger, acquisition or strategic alliance and partnership. We can outline a strategic planning and execution with consequential steps to be taken, like the legal and regulatory aspects of the negotiations, submission of the request of MAH change, We can support the due diligence and formulate a regulatory benefit/risk assessment.

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RA-CMC

Having worked for large (bio)pharmaceutical industry companies and regulatory agencies, our consultants are well-suited to help you to determine an optimal CMC regulatory strategy for your product and ensure the documentation is consistent, of high quality and technically valid. Our consultants support the RA writing process whether that may feed into all possible submissions including in agreement with the CTD Module 3 format for both clinical trial applications (e.g. IMPD & IND) and applications for marketing authorization (e.g. MAA, BLA). We are used to work in close collaboration with involved experts in development, manufacturing, QA, QC and RA, but in addition, we are also able to provide this expertise to your project when needed.

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RA – Clinical

Xendo’s RA specialists support your clinical and medical activities by combining scientific understanding in these fields with knowledge on regulatory procedures. We work together with your physicians, clinical pharmacologists, safety officers and medical directors, guiding them through the regulations and facilitate discussions between the development teams and regulators. We put scientific progress and goals into context of obtaining and maintaining regulatory product approval.

Clinical and medical RA provides services in the clinical development phase as well as in the post-marketing phase of a product. Clinical and medical RA experts can define and lead planning and execution of regulatory strategies in all aspects of the product life cycle across therapeutic areas and can be your health authority liaison for clinical and medical affairs related topics. We manage and execute clinical efficacy and safety-related regulatory submissions and make sure the scientific message and study results are incorporated convincingly across the submission dossier. We take care of project management and authoring of global and local product information.

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Scientific Advice Support

Our consultants can assist you with requests for Scientific advice and/or MAA pre-submission advice. This advice can focus on issues related to phase I/II or III clinical study design, product-specific, legal, regulatory and/or logistic issues.

The process surrounding Scientific advice can be fully outsourced including: pre-meeting, briefing-package, debriefing and analysis of the scientific outcome.

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Environmental Risk Assessment / GMO

Any activities involving Genetically Modified Organism (GMO) are subject to an environmental risk Assessment (ERA) before initiation. Subsequently, the appropriate risk management strategy can be decided upon to mitigate potential adverse effects. Our experts have the seniority to set up these assessments completely, including relevant planned activities and risk management procedures for each GMO. The same experience allows them to determine the potential interaction between GMO(s) and the receiving environment to prevent environmental risk.

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Regulatory Dossier Writing

We are experienced with the writing of all 5 modules of the CTD. Our CMC and quality experts are involved in a broad spectrum of Technical writing activities, such as regulatory variations, eCTD, IMPD, IND information and responses to regulatory authorities concerning questions on CMC matters.

For Medical Devices, a variety of set-ups can be chosen from which to write the Technical Documentation. We strongly advise to apply the STeD set-up in order to facilitate a worldwide regulatory submission; we are experienced in generating STeDs for all classes of Medical Devices and In Vitro Diagnostics. We also have broad and in-depth expertise in writing all elements required for the Technical Documentation / Design History File

We can advise and support the development and outline of your CMC or Medical Device strategy, provide CMC or Medical Device specific project management, select and interact with your CMO and author your CMC or Technical documentation needed for regulatory submissions.

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RA-Maintenance & Compliance

The vast majority of all activities for medicinal products and medical devices relates to maintenance of existing marketing authorizations. These activities have a high economic value as they are needed to assure the continuation of market access of your product. However, dealing with regulatory maintenance is often not related to the strategic regulatory focus of your regulatory team. In addition, regulatory maintenance can often result in peaks in the workload, which for many companies is challenging to cope with. In order to deal with these challenges, Xendo can take care of your regulatory activities by means of our Strategic Maintenance Partnership. Concretely, This means Xendo takes care of the overview and execution of all ongoing and new variations to the registration dossier of your (older) existing products, including the implementation. This would allow your regulatory affairs team to focus on other core regulatory challenges.

Results and advantages working with Strategic Maintenance Partnership:

  • Dossier updated within pre-defined timelines
  • No more peaks in workload
  • Exchange of documents through interface
  • Convenient and smooth collaboration
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Data Management and IDMP

Validation of computerized systems becomes increasingly important in controlled environments. Preferably, we work closely with your QM group and start with a thorough analysis of the data context, subsequently advising on the best way forward; taking resources, technology, and regulatory requirements into account. Our experts combine experience from IT and business allowing them to translate technicalities into a tailor-made project. The European Medicines Agency (EMA) is in the process of implementing the standards for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. We developed a structure to help you with collecting and submisson of the data.