CMC Activities
Scendea’s expert team delivers strategic and operational support in the fields of Non-Clinical, CMC, Clinical and Regulatory Affairs.
CMCCMC Drug Development Plan
A CMC Drug Development Plan is a strategic and comprehensive document that outlines the strategy and processes involved in developing a new drug product, including the chemical properties, manufacturing processes, and quality controls. At Scendea, our capabilities encompass two fundamental services: the generation of CMC Development Plans and conducting thorough reviews of existing CMC Development Plans. Scendea takes a strategic approach to preparing CMC Development Plans, that address the specific needs of your product. We carefully consider factors such as compound complexity, manufacturing processes, and regulatory pathways to ensure a plan that guides your product's development effectively.
CMC Gap Analysis
A CMC Gap Analysis delves into the critical aspects of CMC, identifying potential obstacles that could impede your progress to the next developmental stage. At Scendea, we offer this activity at any stage of your program's journey, ensuring that your pathway to approval remains unobstructed.
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.
Master Files
Our expert team is adept at crafting detailed master files tailored to your unique product specifications. We navigate the complexities of regulatory requirements with precision, compiling all essential data, from design specifications to quality control procedures.
We can provide strategy/preparation, submission, and maintenance support for the following Master Files:
Drug Master File (DMF) – US
Active Substance Master File (ASMF) – EU
Vaccine Antigen Master File (VAMF) – EU
Plasma Master File (PMF) – EU
Programme/Project Management
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.
Technical CMC Support & Troubleshooting
We offer dedicated Technical CMC Support and Troubleshooting services, including but not limited to:
CMC Strategy Support
Manufacturing Process Development & Validation
Product & Process Characterisation Support
Assay Development & Validation Support
Control Strategy & Stability
Technical/Medical Writing
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When embarking on clinical trials across EU Member States, the IMPD serves as a mandatory submission, holding pivotal importance. Our expertise extends to the comprehensive authoring and meticulous review of your IMPD, ensuring that critical information regarding the quality, manufacturing, and control facets of Investigational Medicinal Products (IMPs), encompassing reference products and placebos, is accurately documented. Our approach integrates data derived from both non-clinical and clinical studies, presenting a well-rounded and holistic overview of the investigational product in consideration.
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Scendea provides specialised support for IND/NDA/BLA and MAA licensing applications, offering expert review, revision, and authoring of Modules 2.3 and 3, including sign off/expert assessments.
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Scendea can support with a number of CMC focussed Development Reports, providing an in-depth analysis of various technical aspects related to a product, process, or project.
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 GMP auditing, further ensuring the success, efficiency, and quality of your non-clinical studies.
FDA Platform Designation
The FDA’s Platform Designation offers an expedited pathway for the development of drugs and biologics that leverage platform technologies to standardise development, manufacturing, or processing. Scendea provides expert support to help you navigate the designation request process efficiently and effectively.
Our team can assist with:
Developing a clear strategy to strengthen your designation request.
Preparing or reviewing submission documents to ensure regulatory alignment.
Providing procedural guidance to streamline the approval process.
FDA Advanced Manufacturing Technologies (AMT) Designation
The FDA’s AMT Designation Program supports the use of innovative manufacturing technologies that enhance efficiency, reliability, and supply chain resilience. This designation facilitates the development of drugs and biologics produced using advanced manufacturing approaches, helping to improve patient access to high-quality medicines.
Scendea will review the documents provided by the sponsor and generate the AMT designation request, ensuring a well-structured and compelling submission.
Our team provides:
Expert assessment of supporting documentation to align with FDA expectations.
Preparation of a clear and concise AMT designation request.
Procedural guidance to facilitate a smooth submission process.
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.
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 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
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
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
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