Discovery / Non-clinical
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
Needed expertise for biosimilar regulatory strategy and support with execution
Manufacturing Chemist: Sebastian Joseph discusses regulatory expectations for the non-clinical development of vaccines
A client faces multiple batch rejection due to outdated Internal Release Limits (IRLs) but he has 100+ products (500+ attributes) to analyze and follow up on a regular basis
- 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
- 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
-Early access medicines scheme (UK)
-Hospital exemption (DE)
-Pediatric Investigational Plan (PIP)
-Pharmacovigilance: DSUR and PSUR
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.
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.
Post-approval / Maintenance
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.
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.
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.