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A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis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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End of Phase-2 meeting

European client entering a pivotal program in a competitive market

  • EU based company developing a gastrointestinal product in a competitive and controversial market (opioids)
  • The company intends to pursue adaptive Phase 2/3 clinical program to expedite late-stage development
  • Company intent to gain agreement from FDA on completion of non-clinical and CMC (quality) program to support marketing approval

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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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Veeva Vault RIM Implementation

Limited internal resources and minimal experience with RIM implementation projects

  • US-headquartered biopharmaceutical company with European affiliate
  • First NDA approved; further, NDAs planned
  • Fast-growing company with increasing Regulatory needs
  • Limited resources for project management and operational work during configuration and implement phase
  • Minimal experience with RIM implementation projects and no experience with Veeva Vault

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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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Strategic outsourcing of mature product portfolio

Global innovator company.

  • Wanted to outsource parts of their mature product portfolio.
  • >60 products in different therapeutic areas
  • 430 MAs in Europe, 1,900 MAs internationally (incl. CN, AUS, CAN).
  • Scope of PharmaLex support:
    • Full regulatory product responsibility
    • GRA CMC Manager
    • All publishing and submission activities
    • Piloting of PV and Medical Affairs interface.

 

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Portfolio maintenance outsourcing in highly volatile environment

Large global portfolio to be managed while client organization underwent drastic transformations

  • Portfolio of 35 products in scope.
  • Client went through several significant changes in internal organization in a short timeframe.
  • Multi-supplier situation.
  • Major remediation needs regarding change control and labeling.

 

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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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End-2-end portfolio maintenance (outsourcing) program

Large unstructured source repository and limited timeframe

  • Diverse stakeholders within M&A activity.
  • Short preparation timelines.
  • Regulatory activities across the world (EU, CIS, APAC, MENA, Africa, LATAM).
  • Part integration into client Quality systems.

 

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Post–M&A PharmaLex program governance

Start-up Pharma company with no REG, PV, Quality infrastructure with urgent need for Programme Governance to be established

  • Major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets) .
  • No ability to support program governance of multi-functional Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) operational activities
  • Required urgent support to provide operational activities and oversight, with the ability to establish an appropriate program governance model as required for a Pharmaceutical company.

 

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Post–M&A pharma infrastructure development

Start-up Pharma company with no REG, PV, Quality systems infrastructure, processes and limited personnel

  • Client start-up with major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets).
  • Client has no Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) capacities in-house (neither globally nor locally) to take care of the acquired portfolio and no established systems, tools or processes.
  • Needed support to handle all MAH transfers and subsequent maintenance activities for RA, PV and QM on global and local level.

 

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M&A early strategy

Need for significant M&A strategy experience and expertise to support development of divestment framework

  • Needed expert support for the negotiation phase of a significant divestment of a business unit, during negotiation and strategy development phases.
  • Wanted external support to contribute to separation agreement, transitional service agreements (TSAs) and marketing authorization transfer (MAT) planning / implementation phases
  • Challenge to simplify the complexity of MATs to a simple model for ease of communication.

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Lifecycle management for drug products

Reluctance to compute tolerance intervals

  • Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
    • To reflect the current status of manufacturing process and state of the scientific art analytical procedures
    • To close gaps and achieve GMP compliance of regulatory documentation.
  • Required on-going lifecycle management for all drug product licences needed.

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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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Full PV service outsourcing

Lack of capability of handling unpredictable and fluctuating amount of cases

  • Client required outsourced PV service.
  • QPPV, database set-up and maintenance case management (clinical and post-marketing).
  • Case workflow set-up from initial receipt to reporting.
  • Listings and query support from database.
  • Reporting compliance responsibility.
  • PSMF maintenance.

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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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Local lifecycle Regulatory Affairs management

Local affiliates require support for mature product portfolio in DE / FR / IT

Global life science company.

  • Responsible for product portfolio needed.
    • Handling of local tasks and procedure management handled by one person on client site.
    • Contact person for HA requests needed.
    • Ability to correspond fluently in local language is crucial.

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Due diligence of the dossier documentation for a medicinal product

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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Multi-country Phase III clinical trial support

Market specific CTA applications for a multi-country EU Phase III clinical trial

  • Assistance required to review core documentation.
  • Authoring of local documentation for country specific submissions.
  • Assistance with competent authority and ethics committee communication.
  • Support with handling of substantial amendments to competent authorities and ethics committees, as required.

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US-UK Phase II clinical trial support

Support for timely approval of a Phase II clinical trial in the US and UK

  • Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
  • Alongside support in authoring of IMPD and local documentation required for submission to MHRA.

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Preparation, submission and coordination of a Centralized Procedure (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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Strategy and delivery of global biosimilar development program

Needed expertise for biosimilar regulatory strategy and support with execution

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ERA for an active substance in antiseptic lozenges

Environmental Risk Assessment accepted by environmental agency; costs manageable

  • Client developed antiseptic lozenges for the treatment of sore throat.
  • Support was needed for compilation of an ERA.
  • Scope of required studies was unclear.
  • High costs for anticipated experimental study set.
  • Scientific Advice meeting at environmental agency required.
  • Contract research laboratories required for experimental work.

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Quality Management System

Client was a large Canadian pharmaceutical company requiring an experienced provider to develop the Quality Management System for their supply chain and distribution office.

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