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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Regulatory 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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MA 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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Dendritic 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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Regulatory 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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Definition 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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Pre-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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Type 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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RIM-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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Consultancy 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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Consultancy 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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Global 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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Regulatory 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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Flexible 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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eCTD 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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Regulatory 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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Due 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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Preparation & 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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