Regulatory Activities
Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory Affairs.
RegulatoryRegulatory Approval to Undertake Clinical Studies
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The creation of an Investigational New Drug (IND) dossier is a critical step in seeking FDA authorisation for human clinical trials and interstate shipment of an experimental drug. This dossier serves as the foundation for these activities before marketing application approval is granted. With expertise spanning Non-clinical, CMC, and Clinical aspects, our experts intricately integrate these vital elements into your IND dossier, ensuring seamless alignment with the FDA's rigorous standards, positioning your submission for success by being comprehensive and precise.
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A CTA is a regulatory application submitted to the UK MHRA and/or EU authorities, outlining comprehensive details of a proposed clinical trial, including study objectives, design, participant criteria, and safety measures, seeking approval to conduct the research in compliance with established regulatory standards. Scendea excels in the meticulous compilation and submission of CTA Applications, encompassing both UK MHRA and EU regulatory requirements, ensuring seamless and compliant processes for initiating clinical trials.
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A New Drug Application (NDA) or Biologics License Application (BLA) is a regulatory submission for the approval of a new medicinal product. This comprehensive application encompasses exhaustive details on the product's safety, efficacy, and quality, including data from clinical trials, manufacturing processes, and risk-benefit assessments. Scendea specialises in the compilation and submission of NDA/BLA documents, ensuring alignment with FDA regulatory standards.
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A Marketing Authorisation Application (MAA) is a detailed regulatory submission, provided to both EMA and the MHRA, thoroughly outlining a medicinal product's safety, efficacy, and quality. Scendea specialises in efficiently compiling and submitting MAAs, helping secure approval for commercialisation.
US/EU/UK Regulatory Strategy
At Scendea, we understand that a well-crafted global regulatory strategy is pivotal to the successful launch of your product on a global scale. Our expert team specialises in guiding you through the intricate landscape of regulatory requirements, ensuring a seamless journey from concept to market entry. The tangible output of our Global Regulatory Strategy activity is a meticulously crafted regulatory strategy report. This document provides actionable insights and recommendations, giving you a clear understanding of the steps needed to bring your product to market. In addition to regulatory strategy report authoring, we also offer a comprehensive review service.
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
CBER Advanced Technologies Team (CATT) Program
Scendea will support in generating the meeting request for the CATT program based on detailed discussions and the information provided by you. Our services include:
Expert assessment of the advanced manufacturing technologies to ensure alignment with FDA’s expectations for the CATT program.
Preparation of a clear and compelling meeting request that highlights the significance of the novel technologies and their potential impact on the development process.
Procedural guidance to navigate the submission process and ensure a well-structured request.
Draft preparation of the meeting request document for review, incorporating feedback from you.
Finalisation of the request document for submission to the FDA.
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
EMA Quality Innovation Group (QIG)
Scendea will assist in preparing the submission for the EMA Quality Innovation Group (QIG) based on your requirements. Our services include:
Expert advice on regulatory requirements
Preparation of detailed submissions aligned with the QIG's work programme
Draft and review the request for advice
Finalise the submission for EMA’s QIG following scientific advice procedural timelines.
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MHRA Scientific Advice
Pre-Submission Meetings
Designations
A 'drug designation' refers to a specific regulatory status or classification assigned to a pharmaceutical product by a regulatory agency, such as the US - FDA, EU - EMA, UK - MHRA or other national authorities. These designations are used to streamline the development and review processes for new drugs and therapies.
Scendea offers assistance in determining your eligibility for the following designations and provides support in obtaining them if you qualify.
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Orphan Drug Designation (ODD) US
Regenerative Medicine Advanced Therapy Designation (RMAT)
Breakthrough Designation
Fast Track Designation
Rare Pediatric Designation
Priority Review Voucher
Qualified Infectious Disease Product (QIDP)
FDA Platform Designation
FDA Advanced Manufacturing Technologies (AMT) Designation
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Orphan Drug Designation (ODD) EU
CAT Classification
PRIME
SME Status
Certificate of Suitability (CEP)
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Early Access to Medicines Scheme (EAMS)
Innovative Licensing and Access Pathway (ILAP)
SME Status
Paediatric Development
Scendea provides comprehensive support with paediatric development, including but not limited to:
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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.
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 (non-clinical, CMC, and clinical, as applicable), as well as the proposed duration of deferral, as applicable. The strategy plan, once agreed, will serve as the basis for preparation of the PIP.
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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.
Target Product Profile (TPP) Development
A Target Product Profile (TPP) serves as a blueprint, outlining the specific attributes a product should possess to effectively address a particular disease or diseases. It encompasses intended use, target populations, and essential attributes, including safety and efficacy-related qualities. TPPs are dynamic documents, continuously evolving throughout the development process to align with progress and insights.
At Scendea, we craft TPPs at the onset of development, providing you with a solid foundation. Additionally, we offer ongoing support in maintaining and refining these profiles as your development journey unfolds.
Pre-Submission Interactions
Pre-submission meetings offer an early opportunity to engage with regulatory agencies and are integral in validating and streamlining the evaluation process for marketing applications. Scendea has effectively conducted pre-submission meetings with the FDA, EMA, as well as other national authorities. As a result, we possess the necessary expertise and experience to assist you in strategizing and executing these interactions to enhance your submission strategy.
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
Procedural Aspects
At Scendea, we excel in managing the procedural aspects of securing marketing authorisation.
Our comprehensive services include:
Efficient Project Management
Our team adeptly oversees your regulatory journey, ensuring meticulous timeline adherence and effective management of procedural complexities.
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