Maintain business continuity during merger
- Transfer of GDP-activities to a new site under jurisdiction of a new competent authority
- Application for new Wholesale Distribution Authorization and new inspection required
- QMS to be adapted and targeted to the new lean organization
- Staff fluctuation, limited human resources
- Backlogs in certain operational activities
- Tough milestones to maintain business continuity
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
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
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
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
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
Needed to perform multiple calibration studies for IVD
- A client selling In VitroDiagnostics (IVD) tools had to perform laborious studies to establish the frequency of calibration to be applied on their IVD tools
- Knowing that the required calibration frequency is directly linked to the stability of the reagents used, why not use stability data to predict a calibration frequency that still guarantees performance of the assay?
Support required for process characterization activities
- The client has produced several batches of product and wishes to use the different results from the manufacturing campaign to start process characterization activities
- A large dataset is provided containing information on process parameters and material attributes across the process
- Client project was blocked due to lack of internal process characterization capabilities
Required support for recruitment of patients for clinical trials
- In many clinical trials, the amount of time needed to recruit the targeted number of patients is underestimated
- Failure to recruit enough patients in the planned time frame causes delays, additional costs, etc
- Consequently, estimating the recruitment duration is of crucial importance for the proper conduct of the trial
Manual process for recording data was unreliable and expensive
- The client installed accelerometers on mice to record disease events
- The system detected c.100 false positives for each real event
- Results needed to be reviewed and corrected manually by experts
- Data accuracy critical as data set was aimed to be used in pre-clinical trials to compare different treatments
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.
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.
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
Outsourcing clinical trial safety activities to PharmaLex assures compliance and puts project on track for fast registration
- A US company was dissatisfied with a large global CRO’s study and drug safety management for a programme of multinational clinical trials involving a complex drug device combination therapy. These ongoing studies were pivotal to the successful registration of the treatment in the EU and US. PharmaLexwas given responsibility for all the clinical trial safety activities.
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
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
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
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
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
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
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
- 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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Needed expertise for biosimilar regulatory strategy and support with execution
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.