Resource Library: Case Studies

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.

Posted: 23rd June 2020

Strategy and delivery of global biosimilar development program

Needed expertise for biosimilar regulatory strategy and support with execution

Posted: 23rd June 2020

Preparation, submission and coordination of a Centralized Procedure (CP) for PUMA formulation

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.

Posted: 23rd June 2020

US-UK Phase II clinical trial support

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.

Posted: 24th June 2020

Multi-country Phase III clinical trial support

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.

Posted: 24th June 2020

Due diligence of the dossier documentation for a medicinal product

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).

Posted: 24th June 2020

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.

Posted: 24th June 2020

Regulatory publishing support on request

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.

Posted: 24th June 2020

eCTD submissions for global DMF portfolio

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.

Posted: 24th June 2020

Flexible eCTD publishing support

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

Regulatory CMC compliance reduced workload by 20-25%

High additional workload due to expansion in product portfolio

• More than 150 different formulations, resulting in more than 1200 national registration documentations worldwide.

Posted: 24th June 2020

 Lifecycle management for drug products

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

Global CMC responsibility during portfolio integration

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.

Posted: 24th June 2020

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.

Posted: 24th June 2020

Quality Management System

Client was a large Canadian pharmaceutical company requiring an experienced provider to develop the Quality Management System for their supply chain and distribution office.

Posted: 3rd October 2018