Safety Writing Services

Client looking to outsource PV activities to focus on core business activities and compliance function

  • Need to increase the resources available for PV activities without increasing company assets
  • Interest to have support from PV experts and collaborate with a service provider focused on PV
  • Mitigate the risk of quality issues raised during inspections from health authorities

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Aggregate Report Writing and RMPs

Quality issues raised during inspections related to the source data

  • Client needs to handle increased workload in Pharmacovigilance
  • Need to reorganize Pharmacovigilance activities outsourcing those that can be easily trained and transferred
  • Client looking for an external provider to focus on PV and extensive experience in safety writing

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Remediation Activities and Operational Support for local GDP Quality and PV Systems

German affiliate of a large US company requiring maintenance support for local GDP Quality and PV Systems

  • Looking for alternatives for their current cooperation with 2 freelancers for maintenance activities (one for GDP, one for PV). Wish to have one consultant for both areas
  • Customer considered his GDP Quality and PV Systems up-to-date
  • Limited internal staff and local know-how
  • Local PV-responsible requested
  • Specified operational GDP- and PV activities requested

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Business Readiness for new German Affiliate

Newly founded German affiliate needed short-termbusiness readiness

  • Globally acting company (small-medium size) founded a German affiliate due to re-organization
  • Affiliate needed business readiness on short term (termination of contracts for precious business solutions, own sales)
  • Design of a new GDP Quality System (needed to apply for and obtain WDA*)
  • Local Pharmacovigilance support and provision of the local PV-responsible
  • Lean processes (limited resources)

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Pre-IND Meeting for an antibody-drug conjugate (ADC) for an advanced cancer indication

Client in need of expertise for IND development and FDA interaction for First-in-Human study

  • European SME beginning first discussions with the FDA regarding IND development and submission of an ADC product for an advanced cancer indication
  • Intent to gain agreement on completed nonclinical program to support first in-human (FIH) study

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Medical Information Service for mid-sized pharma company

Mid-size pharma company with personnel shortage for Medical Information Services

  • Mid-size pharmaceutical company acquiring well-established European OTC product portfolio from global pharmaceutical company
  • Personnel shortage therefore outsourcing of Medical Information (MI) support for DE / CH / AT / PT / GR / HU / CZ / NO / SE
  • PharmaLex project lead support company’s project leads working in collaboration with internal functions and MI call center vendor on tasks related to oversight and management of MI support

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Medical Information Service for large pharma company

Client was a global large pharma company
Due to personnel shortages client was in need of support for:

  • PQCs documentation and management of field sample retrieval
  • Technical and medical queries documentation in a harmonized way that allows extracting of patterns and data for quarterly / yearly reports
  • Advance knowledge in Pharmacovigilance that allows the team to recognize adverse events and medication errors quickly and efficiently

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Full service Post-Marketing Pharmacovigilance and Medical Information Services for large nutritional health company

Rapid set up and go live for  PV and Med Info Services

  • Large nutritional health company with newly acquired Rx products in US and Canada required urgent full support with all PV activities, Medical Information contact center services, as well as data migration of cases from prior MAH
  • New to prescription drug market with 3-week timeline to take over PV and Call Center responsibilities
  • Need of additional support for NDA maintenance support, promotional materials development and review, and product complaint management

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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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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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Full service post-marketing and clinical trial PV activities for mid-sized pharma company

  • US company developing a modified release formulation for an existing active ingredient needed full support with all routine PV activities, as well as migration of the global safety database
  • Expanding to new markets and awaiting approval in EU and Canada
  • Needed support for introduction of new products into the EU as well as further expansion in the US
  • Needed local presence in the EU to liaise with their marketing partners without the need to set up their own infrastructure
  • Dynamic growth of company required flexible up- and down-scaling of resources

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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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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 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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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 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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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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