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.