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Parallel NDA/MAA eCTD Submission
3 dossiers (an NDA and 2 MAA) for initial application for DP for prevention of pregnancy
- Dossiers for EMA and FDA with differences in the requirements
- Support for the client (one US NDA and one EU MAA) and their third-party collaboration partner (one additional EU MAA)
- Differences in the administrative part of the dossiers and following updates of M1 and M2 documents
- Short notice changes before the planned submission dates due to difficult alignment between affected parties
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DownloadRegulatory Operations IND transition to eCTD
PharmaLex network of resources and experience utilized to guide the client to success
- CMC subject matter expertise for gene therapy was provided to effectively map eCTD locations of legacy documents
- Anchor eCTD submissions were established and dispatched through the FDA electronic submissions gateway to begin the eCTD submission management
- Experienced regulatory operations managers guided the client regarding the nature of lifecycle operators and eCTD granularity
- Technical support was provided for eCTD templates
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DownloadMA applications to EMA and FDA in parallel
- A European pharmaceutical company has identified the need for support from a service provider due to the lack of capacities and capabilities to process both applications in parallel
- Support for various regulatory activities in relation to the preparation, submission and coordination of both applications (EU/US)
- Outstanding Project Management expertise required to meet requirements of large project
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DownloadDendritic cell vaccine (oncology)
- Small biotech US company developing a dendritic cell vaccine for the treatment of the Orphan indication glioblastoma in EU
- Timeline: long-term (8 years)
- Support in
-Preparation and conduct of the Scientific Advices (SA)
-Medical and technical Writing
-Clinical trial Phase III
-Adaptive pathway
-Early access medicines scheme (UK)
-Hospital exemption (DE)
-Pediatric Investigational Plan (PIP)
-Pharmacovigilance: DSUR and PSUR
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DownloadRegulatory CMC Compliance reduced risk
- Identified deficiencies in Change Control procedures and GMP manufacturing documentation
- Uncertainty in verifying the current registered information held with Health Authorities
- Lack of Regulatory Information Management (RIM) systems and therefore lack of oversight of product information for key stakeholders
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DownloadDefinition of batches internal release limits based on stability results
A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis
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DownloadPre-IND Meeting
- Company beginning first discussions with the FDA regarding IND development and submission of intra-cerebral gene therapy product
- Intent to gain agreement on completed nonclinical program to support first in human study
- Intent to gain agreement on the use of historical controls to support clinical development in rare disease space
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DownloadType C Meeting
US Company developing a patient-reported outcome (PRO) as the primary endpoint for the Phase 3 program
- Under guidance from FDA, the company performed multiple Phase 1 and 2 studies to support validation of PRO efficacy measuring tool
- Company intent to gain agreement on validation of PRO for use in Phase 3 studies to support small molecule development for celiac disease
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DownloadRIM-DMS Data Clean-up
300 GB of unstructured and partially structured documents, and files during marketing authorization transfer
- The client acquired a large portfolio of marketing authorizations
- Data transfer was documented, but documents and files were highly unstructured
- Fully structured and valid data, documents and files to be imported into Veeva Vault RIM
- Timelines for the project defined by marketing authorization transfer submissions and any regulatory maintenance activities
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DownloadConsultancy and eCTD submission support for master files
Manufacturer with limited eCTD knowledge and several Holder’s sites in the EU, US and China
- Client needs to switch Master Files (MF) to eCTD format in EU, non-EU and US (later also APAC, CA)
- Pressure from their clients (MAHs) to use eCTD
- PharmaLex supported with:
- Knowledge transfer, Project planning + management
- Gap analysis and roadmap for transition
- Full Regulatory Operations services during transition and on-going maintenance of eCTD-MFs (eCTD-readiness, compile, publish, submit)
- Consultancy on CMC and (pre-)publishing topics and tools
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DownloadConsultancy and support for IDMP implementation
- Medium-sized pharmaceutical company in the EU
- Client intends to prepare for upcoming IDMP implementation in Europe
- Focus on compliance and optimal utilization of related information within the company
- PharmaLex supported with:
- Awareness meetings
- Gap analysis
- Implementation proposal covering systems, processes and data
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DownloadGlobal CMC responsibility during portfolio integration
Tight contractual agreed timeframe and multiple data migrations and process adaptations
- Portfolio acquired by client for which CMC maintenance already handled by PharmaLex >8 years before acquisition.
- PharmaLex with same functional role in new company but different scope of work.
- Compliance with changing client processes due to data migration.
- Portfolio with > 80 INNs (chemicals, herbals, biologics) authorized worldwide.
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DownloadRegulatory CMC compliance reduced workload by 20-25%
High additional workload due to expansion in product portfolio
- More than 150 different formulations, resulting in more than 1200 national registration documentations worldwide.
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DownloadFlexible eCTD publishing support
Global innovator company looking for flexible support and ability to meet tight deadlines
- Global innovator company and European generics arm requiring UK local affiliate support.
- Covering MAAs and post-approval submissions.
- More than 250 MAs
- Typically 25 – 30 eCTD sequences required per week across the portfolio.
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DownloadeCTD submissions for global DMF portfolio
Client was lacking internal expertise during workload peaks
- Big multi-national chemical company.
- Client intended to switch all existing Drug Master Files (DMF – active substances as well as excipients) into eCTD format.
- Portfolio also included Veterinary Master Files, which require a specific electronic submission format.
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DownloadRegulatory publishing support on request
Client lacking resources for EU publishing activities
- Global generic company needed support for EU publishing activities for parts of its product portfolio.
- All EU eSubmission activities (eCTD, NeeS) were transferred to PharmaLex.
- Scope of PharmaLex responsibilities:
- Direct correspondence and interactions with Regulatory Affairs functions.
- Collection of related documentation.
- All dossier as well as submission activities.
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DownloadDue diligence for medicinal product documentation
Evaluation of drug product documentation under time pressure
- Medium-sized EU-based pharmaceutical company.
- The client intended to acquire the marketing authorizations for three strengths of an oral anti-diabetic medicinal product intended for use in patients with type II diabetes.
- Client was in the need of due diligence to review the dossier and assess the quality of a planned acquisition by the company before imminent expiry (Sunset Clause).
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DownloadPreparation & submission of a CP for PUMA formulation
Needed expertise for regulatory strategy and support for execution for CP and PUMA formulation
- A small European pharmaceutical company has identified the need for support due to lack of capacity and capability to process a centralized procedure for a PUMA formulation.
- PharmaLex offered support for various regulatory activities in relation to the preparation, submission and coordination of the centralized procedure.
- Project management.
- Definition and tracking of KPIs and budget.
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