Case Processing Services

Case Processing Services

  • High number of ICSRs received daily from different sources WW (10,000+ ICSRs / year)
  • Challenging internal timelines for PV activities
  • Limited resources in the client affiliates.
  • High volume of SOPs and Working Practices to follow daily
  • Harmonization of processes in all local affiliates: China, Italy, Brazil, Venezuela, UK, The Netherlands, Peru, Belgium, Australia, Romania, Canada and US

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Support with retrieval of ICSR Follow-Up information

Support with retrieval of ICSR Follow-Up information

  • ICSR processing carried out within the client organization following client’s procedural documents
  • Need to outsource retrieval of follow-Up information as one single part of ICSR processing due to limited resources
  • Wish to streamline the process with only one preferred service provider
  • Integration of PharmaLex personnel into given processes and procedural documents

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Global PV Outsourcing

Global PV Outsourcing

  • Globally operating pharma company requested support concerning quality management and operative PV activities with the focus on case processing
  • Client was thus looking for one preferred service provider with an international company structure
  • Responsibilities included all workflows and activities relevant for case processing and quality management

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Full PV Outsourcing of a Global Generics Pharma Company

Full PV Outsourcing of a Global Generics Pharma Company

  • The company was new founded and took over a significant number of products from another MAHs woman’s health portfolio
  • No PV system or other PV related structures where in place
  • Local structures needed to be established in 45 countries
  • PharmaLex offers:
    • Set up of a completely new pharmacovigilance (PV) system including QPPV, LPPVs, PSMF, PV SOP updates, and data migration to new safety database
    • Maintenance of the PV System after marketing authorizations were transferred to the new MAH

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Safety Detection and Signal Management

Efficient End to End Pharmacovigilance services according to GVP

  • The marketing authorisation holder in the EU should continuously monitor the safety of their medicinal products and inform the authorities of any new information that might have an impact on the marketing authorisation [DIR Art 23(2), REG Art 16(2)](GVP Module IX)
  • Client was rapidly increasing portfolio with M&A with over 1500 marketing authorizations with complex partner network systems
  • Implement a process for integrating the activities performed by PharmaLex into the client’s system

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PharmaLex successfully changes legal status of product from POM to P

PharmaLex successfully changes the legal status of the product from POM to P

  • PharmaLex leveraged their regulatory expertise on the switching requirements and process, and their working relationship with the regulatory authorities to successfully change a product from prescription only medicine (POM) to pharmacy medicine status.

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PharmaLex keeps medical device CE marking on track

PharmaLex applies expert knowledge of EU medical device regulation and achieves a positive opinion from the MHRA on a Class III medical device, despite a flawed study design.

  • A US-based company developed a class III medical device with an ancillary medicinal product (according to Rule 13, Annex IX of the Medical Device Directive 93/42/EEC).  The data were positive in a multi-center, randomised, comparative clinical trial but a prospective protocol-defined primary endpoint was flawed and unfortunately this led to early termination of the study.  With the risk of needing to repeat the trial, the company required a partner with specialist knowledge of EU medical device regulations and strong Notified Body experience to avoid a significant delay and costly consequence.

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PharmaLex expertise secures CE certification for medical devices ‘at risk’

PharmaLex expertise secures CE certification for medical devices ‘at risk’

  • An EU based company manufacture a large portfolio of medical devices for the UK National Health Service. During a recent Notified Body audit, the company’s Technical Files were found to be deficient, and they were issued with a major non conformity against their Clinical Evaluation Reports (CERs).
  • With multiple reports requiring update to the new MEDDEV 2.7.1/rev4, there was a real risk of losing their CE certifications and thus, the right to sell their products in the EU. This manufacturer required a consultancy specializing in medical devices, who had clinical writing expertise and strong literature retrieval skills, together with the commitment and can do attitude to meet a very tight deadline.

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PharmaLex delivers huge sales upturn with regulatory strategy

PharmaLex ensures regulatory compliance for successful pharmaceutical product acquisition with sales growth of 22% in the first year

  • A pharmaceutical company had an opportunity to buy their first medicine and needed to understand their pharmaceutical regulatory compliance obligations prior to acquisition. This was a product that had been sold for a number ofyears in many countries across the world, so there was a huge amount of complex technical and scientific data. The medicine was used to treat potentially life-threatening infections and therefore played a vital role in critical care.

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PharmaLex corrects serious non-compliance issue

PharmaLex corrects serious non-compliance issue and protects millions of £s of annual sales for product range

  • PharmaLex were given the responsibility of providing regulatory services to a pharmaceutical company who had acquired two licensed medicines in a range of formulations and strengths from big pharma. These originator products had EU sales in the millions and PharmaLex were engaged to provide regulatory support to all the client’s local EU affiliate offices.

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PharmaLex creativity achieves increased cosmetic product sales

PharmaLex devises regulatory strategy for a cosmetic that results in increased cosmetic and medicinal product sales in the dermatology sector for leading OTC / generic company

  • A company wanted to increase public awareness of its dermatology medicine but was unable to do so because regulations did not permit promoting the product to the public.

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PharmaLex obtains rapid CE marking

PharmaLex obtains rapid CE marking for a medical device that opens up a market worth $2.2 billion

  • A US-based company had developed a Class III medical device for the treatment of hepatic cancer. The device had been designed to be used with a specific medicinal product. The company wanted to sell their product in the EU and the product must therefore carry a CE mark.

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PharmaLex applies EU regulatory affairs expertise

PharmaLex applies EU regulatory affairs expertise to rescue failing market application and delivers €3m revenue in first year sales

  • A pharmaceutical company had submitted a marketing application for a new product seeking approval in ten EU countries. The company required a partner with specialist EU regulatory affairs knowledge to avoid a costly failed application.

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Outsourcing pharmacovigilance activities to PharmaLex

Outsourcing pharmacovigilance activities to PharmaLex ensured full compliance and a successful MHRA PV inspection

  • A small company wished to outsource all pharmacovigilance activities. They were in the process of obtaining an EU marketing authorization and license approvals in other countries around the world for their product. As an applicant and future license holder they had to fulfil significant and complex pharmacovigilance obligations.

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Computer Software Validation for Multinational Pharmaceutical Company

Pharmaceutical company acquires a European company and needs to expand in European market

  • Executive management needed deployment of ERP system at the acquired European site to support the anticipated increase in business volume and complex supply chain model
  • The pharmaceutical corporation needed computer software validation to meet US and EU regulatory requirements followed at other company locations
  • Validation efforts necessitated remote support to work alongside implementation team

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Portfolio Maintenance Outsourcing – Global RA responsibility

Outsourcing of global well established products

  • Client was a multinational Swiss-based company
  • Due to capacity constraints the company intended to transfer outsource several mature products of their Consumer Care portfolio (OTC, Food and cosmetics)
  • Within the transfer all maintenance activities including labelling support and electronic publishing should be handled

 

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Portfolio Maintenance Outsourcing Local RA responsibility – EU

Client plans to outsource RA activities in EU countries for defined products

  • High workload in local affiliates for established product portfolio in the EU
  • New products registered in the countries lead to increasing workload
  • Full RA responsibility for an established product portfolio to be outsourced for 16 EU countries
  • Cover of all RA life cycle management tasks including labeling and interaction with local partners (incl. PV, medical)
  • HA interactions done directly by PharmaLex

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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

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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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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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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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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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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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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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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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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