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 international (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.
- 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:
üImplementation proposal covering systems, processes and data.
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.
Needed expertise for biosimilar regulatory strategy and support with execution
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.
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.
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.
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).
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.
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.
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.
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.
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.
High additional workload due to expansion in product portfolio
- More than 150 different formulations, resulting in more than 1200 national registration documentations worldwide.
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 licenses needed.
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.
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.
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.
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.
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.
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.