Non-Clinical Activities
Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory Affairs.
NON-CLINICALNon-Clinical Strategy Workshop - ICH Regions
A Non-Clinical Development Strategy Review and workshop is an exercise that offers a client the opportunity for our team of experts to review your Non-Clinical Development Strategy in relation to ICH and regional guidelines and present any gaps &/or suggestions in the form of a report and workshop to discuss the findings and offer suggestions within the review. A Non-Clinical Development Strategy Review can occur at any stage of development, however, Scendea would typically recommend this activity occurs early in development.
Non-Clinical Drug Development Plan
Scendea can support with the preparation of your Non-Clinical Drug Development Plan (DDP), designed to outline the non-clinical studies required to support the advancement of a drug candidate from R&D to early clinical trials. This is a crucial part of the overall drug development strategy and focuses on evaluating the safety and efficacy of the investigational drug in relevant in vitro and/or in vivo non-clinical models before human testing. Our team offer valuable guidance and strategic insights, ensuring that your Non-Clinical Development Plan aligns with your overall drug development strategy and objectives. We diligently adhere to the stringent regulatory requirements set forth by the US, EU and UK regulatory authorities, paving the way for smooth approval processes.
Non-Clinical Gap Analysis
Non-Clinical Gap Analysis is a fundamental activity in drug development that involves a comprehensive evaluation of the non-clinical aspects of a drug development program. It focuses on identifying potential gaps, deficiencies, and areas for improvement in the non-clinical data and processes that support the advancement of a drug candidate.
Our expert team is skilled in performing Non-Clinical Gap Analysis, whether you are in the early stages of pre-clinical research or preparing for clinical trials, Scendea's tailored approach ensures that we assess the specific needs and challenges of your program, providing valuable insights for decision-making. By leveraging Scendea's insights, you can optimise your drug development strategy, ensuring that your program is well-prepared for successful regulatory submissions and clinical trials.
Vendor Selection & Management
Scendea’s Vendor Selection and Management services include requests for proposal generation, vendor identification and selection, study monitoring, and the critical evaluation of vendor proposals. Our experienced team excels in streamlining these processes, ensuring seamless collaboration and optimal performance. Additionally, we specialise in ongoing vendor management, which guarantees successful completion of contracted activities. Moreover, our proficiency extends to GLP auditing, further ensuring the success, efficiency, and quality of your non-clinical studies.
Non-Clinical/Toxicology Study Design & Protocol Assessment & Development
Non-Clinical/Toxicology Study Design and Protocol Development is a crucial aspect of drug development that involves planning and formulating comprehensive studies to assess the safety and potential toxic effects of investigational drugs before they are tested on human subjects.
Navigating the complexities of regulatory approval is a key challenge in drug development. Scendea's in-depth knowledge of US, EU and UK regulatory guidelines ensures that your Non-Clinical/Toxicology studies comply with the required standards. We assist in preparing and organising the study data for regulatory submissions, enhancing the likelihood of successful approval.
Programme Management & Study Monitoring
Scendea provides specialised programme/project management services tailored towards preparing a client's product for clinical trials or attaining regulatory approval in a streamlined and cost-effective manner. Our comprehensive programme/project management encompasses all aspects, including manufacturing/quality, non-clinical development, and clinical development. Alternatively, we offer focused management services for specific aspects of a development plan.
We excel in generating detailed project plans, creating timeline charts, and implementing robust document/version tracking systems to ensure seamless progress in your projects. We are also able to support with non-clinical study monitoring to support with CRO selection, ensuring that pivotal studies are designed appropriately and that they are conducted to the highest standards and reported with clarity and consistency.
Due Diligence Activities
Whether your objectives involve strategic acquisitions, investments, or out-licensing opportunities, making well-informed decisions requires a meticulous and precise analysis of existing scientific data.
At Scendea, our expert team specialises in both high-level assessments and comprehensive deep dives. Our Due Diligence activities identify crucial gaps in Non-Clinical, CMC, and Clinical data, pinpointing potential risks that could hinder the progression of your projects in US, EU and UK markets.
Non-Clinical Development Issue Identification & Resolution
Non-Clinical development is a multifaceted process that may encounter challenges and issues that could hinder progress. Identifying and resolving these issues swiftly and effectively is crucial to maintaining the momentum of your drug development program. Non-Clinical Development Issue Identification & Resolution involves the meticulous assessment and resolution of obstacles during preclinical stages, ensuring a seamless transition to clinical trials.
By partnering with Scendea, you gain access to insights that optimise your development pathways. Our expert recommendations enhance decision-making, refine study designs, and improve data quality, elevating the overall efficiency and success of your non-clinical development.
Technical/Medical Writing
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Scendea excels in preparing core documents, including Investigator's Brochures (IBs). These meticulously prepared documents are crucial for enlightening investigators and trial stakeholders on essential protocol details, such as dosage, administration methods, dose frequency/interval, and safety monitoring procedures. Our proficiency in Regulatory Guidelines guarantees that your IB aligns seamlessly with standards, encompassing critical non-clinical aspects.
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Scendea provides specialised support for IND/NDA/BLA and MAA licensing applications, offering expert review, revision, and authoring of Modules 2.4, 2.6 and 4.
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Scendea can support with a number of non-clinical focussed Development Reports, providing an in-depth analysis pertaining to a product, process, or project, with a focus on non-clinical considerations
Orphan Drug Designation
Scendea specialises in providing comprehensive support for Orphan Drug Designation (ODD) applications. With our dedicated team, you can navigate the intricacies of ODD applications with confidence, increasing the likelihood of obtaining approval.
Our services include:
Review of non-clinical data to assess if there is sufficient data to support scientific rationale to establish medical plausibility.
Development of an optimal strategy to ensure a successful ODD application.
Expert authoring or thorough review of ODD applications, including prevalence/incidence calculation.
Procedural guidance and submission support, ensuring that every aspect of the ODD process is meticulously managed.
Paediatric Development
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Paediatric Development Strategy Workshops
Our workshops are designed to provide an in-depth assessment of your current paediatric development strategy. We conduct a meticulous analysis of the literature relevant to your indication, ensuring alignment with the requirements of a Paediatric Investigation Plan (PIP) in Europe and the UK. Our experts guide you in refining your strategy, equipping you with the knowledge and insights necessary for successful paediatric development. The non-clinical team can help to identify if Juvenile animal studies will be required to support the PIP.
Paediatric Development Strategy Document
Our strategy document outlines the paediatric subsets where a waiver will be proposed, and include a high-level outline of proposed studies to be included in the Paediatric Investigation Plan (CMC, non-clinical and clinical, as applicable), as well as the proposed duration of deferral, as applicable. The non-clinical team can help to identify if Juvenile animal studies will be required to support the PIP. The strategy plan, once agreed, will serve as the basis for preparation of the PIP.
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A Paediatric Investigation Plan (PIP) - EMA/MHRA and a Pediatric Study Plan (PSP) - US are development plans aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children.
Scendea can support with authoring and/or review of your PIP/PSP (including waiver and deferral applications). We also offer PIP/PSP procedural and submission support and can manage all interactions with the EMA, MHRA and/or FDA.
Agency Interactions
Frequent engagement with global regulators is vital for successful pharmaceutical development. Scendea excels in representing you during critical meetings with the US-FDA, EU-EMA, UK-MHRA and other national authorities. Our team collaborates closely with you to optimise interactions, aligning your strategies with regulatory expectations for a more successful development journey. We also craft comprehensive briefing documents to support regulatory agency/authority interactions, act as the regulatory primary point of contact (including providing US agent services) and promptly respond to agency inquiries. This meticulous approach ensures that every engagement with authorities adds substantial value to your product development.
In addition to the above, we craft well-structured responses to agency inquiries and information requests, maintaining the momentum of your application during evaluations.
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Type A/B (Pre-IND)/C/D
INTERACT Meetings
Pre-BLA/NDA
US Agent Services
Scendea also offers US Agent Services. In this capacity, we assume the role of your US agent throughout the process of IND and Orphan Drug Designation (ODD) applications.
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ITF Meetings
EMA Scientific Advice
National Scientific Advice
Pre-MAA Meetings
Paediatric Scientific Advice
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MHRA Scientific Advice
Pre-Submission Meetings
Authoring & Review of Licensing Applications
We specialise in authoring comprehensive licensing applications in the US and EU, covering every critical aspect for regulatory approval. Our service encompasses the creation of Modules 1 to 5. These modules ensure a structured presentation of administrative information, overall summaries, quality details, non-clinical and clinical study reports, essential for effective regulatory evaluation. Our expertise also extends to providing expert assessment and sign-off for Module 2, offering a crucial layer of assurance for the application's overall summaries. We also offer extensive review and revision of existing licensing applications, ensuring your application adheres rigorously to safety, efficacy, and quality benchmarks.
Discover the list of applications we support…
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NDA
BLA
ANDA
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MAA (Centralised and National Authorisation Procedures)
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MAA
