Variations are usually required when the company wish to update or modify an existing aspect of an already authorised product, avoiding the process of a new application. This may involve changes to the terms of its labelling, formulation, or indication. A supplement, on the other hand, seeks to add a new specification, for example, an extended use of the product, expanding its market, etc. We navigate the scientific and regulatory complexities to ensure that changes are well justified and the impact on the final benefit-risk balance of the product is clearly communicated.

Annual reassessments are prepared by pharmaceutical companies to conduct an annual evaluation of the product performance. They usually report the overall product’s status (including efficacy, safety, and market performance developments), which ensures the product remains compliant with regulatory standards. These documents require the tracking of a wide range of data from different sources. For this reason, we strive to provide a cohesive and synthesise document, ensuring that all key aspects are thoroughly evaluated and communicated.

The PBRER provides a comprehensive and critical analysis of the overall benefit-risk balance of a medicinal product, updated periodically post-authorisation. Unlike PSURs, they must address not only the safety but also the efficacy and effectiveness of the product, which helps to evaluate whether the therapeutic benefits of the product continue to outweigh the risks. The medical writer’s role is essential when planning and managing the submission, ensuring consistency across different sections but also with other pharmacovigilance documents.

PSURs are pharmacovigilance documents aimed to update the benefit-risk balance of a medicinal product after its authorisation. These periodic assessments must include any new information on the safety profile of the product in order to identify new or emergent risks, potential shifts in the balance, and measures to be taken. Writing a PSUR can be challenging, as it requires a critical thorough analysis of large volumes of safety data. We strive to provide timely and compliant deliverables that help identify any potential safety signal.

These regulatory documents are aimed to support the interaction with regulatory authorities (EMA or FDA), which helps to smooth the overall process. They are often prepared for pre-submission meetings, request for scientific advice or even protocol assistance. These interactions can influence the clinical development of a product and are therefore critical to companies. From our side, it is essential to deliver documents that are clear and concise, presenting the points of discussion in a direct and accessible manner.

Within the marketing application process, Integrated Summaries are key documents that combine and analyse data from different studies, grouped into safety, efficacy and immunogenicity summaries. Inherently, they must have a solid statistical basis, which will help regulators gain a well-rounded picture of the medicine’s benefit-risk profile. It is key for us to produce documents that are consistent across multiple studies and traceable to their sources, while maintaining a clear and compelling narrative.

Requests for accelerated assessment are addressed to the European Medicines Agency (EMA) to request an accelerated review of a medicine’s marketing application, particularly indicated for medicines that may have a significant benefit to the public or fill an unmet need. They must be convincing and clearly highlight the importance and advantages over other existing therapies. With a strategic focus, we will strive to deliver well-structured documents with clear arguments that help authorities quickly assess the relevance to public health.

PIPs/PSPs aim to describe in detail the research plan that will be carried out to evaluate the suitability of the investigational product in the paediatric population. They must ensure that sufficient data will be obtained to support their authorisation in children. In such a vulnerable population, it is crucial to align the intended objectives and expectations with the practical aspects of clinical development. With our experience, we will ensure that any potential issues that may arise are handled smoothly to achieve a comprehensive and successful application.

Orphan drug designation is a special status that sponsors can seek when developing a medicinal product to prevent, diagnose or treat a rare disease, a condition that affects a small number of patients. This designation confers significant incentives to sponsors, a strategic way to promote the development and marketing of drugs for rare conditions. Applications can be challenging since data is often scarce and studies usually deal with a heterogeneous population. With our experience, we will tackle these complexities and join forces not only in the application process but also in the maintenance of the subsequent periodic reports.

Pharmaceutical companies may decide to launch/market their products in foreign markets, but to do so, they need to adhere to country-specific clinical and regulatory documents. As a result, it is essential to know how to navigate these complexities in order to streamline the submission process for different worldwide markets. We will support you every step of the way to achieve a compliant and successful global regulatory application.

Responses to written request refer to a document or group of documents created in response to a formal request from regulatory agencies, such as the FDA or EMA, which may solicit further information about the investigational product. These requests might take many forms, such as clarifications, additional data, or follow-up details not included in the original submission. Whatever the request, we will work together to provide tailored responses to satisfy authorities’ requests in a clear and substantive manner.

Regulatory bodies often require revisions or additional data during the approval review stage. These responses are critical to keeping the process on track and moving toward the final authorisation/goal/resolution. That’s why we take care to provide clear responses in a timely and tailored manner for a successful submission process.

These regulatory documents describe how the safety of a medicinal product will be managed and monitored post-authorisation. These plans are essential for preventing and minimising risks in patients and evaluating the effectiveness of the measures taken. As new information becomes available throughout the drug’s lifetime, RMPs/REMS are continually modified and updated. We will adopt a strategic approach in order to provide clear, robust risk documents that anticipate the expectations of regulators authorities.

Clinical Summaries present a comprehensive and factual summarisation of all the clinical information in the Common Technical Document (CTD). Each summary focuses on a specific area and, taken together, they help regulatory authorities to assess how the medicine works, how it is absorbed, how safe it is, and its effectiveness in patients. Therefore, drafting these documents involves synthesizing large amounts of data into focused deliverables. It is paramount for us to provide documents of the highest standard that fully meet these requirements, while maintaining the accuracy of results and consistency across sections.

Clinical Overviews provide an exhaustive and critical analysis of the clinical data, submitted as part of the Common Technical Document (CTD). Its objective is to present the overall clinical findings and implications of the results, highlighting their strengths and limitations, so that regulators can gain a quick overview of the clinical landscape. We will bring our expertise to critically evaluate and integrate the findings from multiple studies, ensuring a well-founded and compelling submission.