Global Headquarter / End-to-end Outsourcing

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    Gain efficiency and reduce costs

    With costs and regulatory complexities on the rise, companies are finding it more challenging than ever to maintain mature product revenue streams. In today’s hyper-competitive market, managing a product post-approval requires the support of a seasoned global partner with unparalleled cross-functional and operational expertise. Minimize these challanges with a Global Headquarter Strategic Outsourcing plan.

    While meeting broad strategic and financial objectives, PharmaLex builds long-term relationships based on synergy and trust. Years of experience translate into our outstanding track record. To date, our solutions serve over 50 pharma companies worldwide—leading large projects at every stage of the product lifecycle to increase efficiency and reduce costs. We’re proud that most of these relationships are ongoing and have become integral to our clients’ success.

    Global network, local expertise

    Our global network of local experts operates seamlessly across countries, cultures and languages. We offer a blend of in-country, near-shore and offshore resources that easily integrate into your company structure,establishing portfolio oversight that’s always centrally managed.

    Our tailored operational models are built on a trifecta of expertise, knowledge and state-of-the-art technology. This approach empowers pharma companies to focus on their core strengths and big-picture decisions rather than tactical activities, such as building technical infrastructures. Ultimately, our global workforce and innovative solutions infuse long-term value into every level of your business.

    Meet the Team

    At PharmaLex, we believe that human connection is the key to success.

    To that end, we foster an environment of timely and transparent communication, where smart business evolves into strong partnerships.

    Stephan Hutter

    Stephan Hütter

    DIRECTOR GLOBAL PROGRAM MANAGEMENT AT PHARMALEX
    Stephan Hütter started his career in the pharmaceutical industry in 2011 joining PharmaLex in 2014 and developing since then in the area of RA and Global Program Management. He is currently the Service Solution Lead for PharmaLex’s Global Headquarter Strategic Outsourcing
    Marie Charlotte

    Dr. Marie-Charlotte von Brevern

    GLOBAL PROGRAM MANAGEMENT DIRECTOR AT PHARMALEX
    Marie-Charlotte von Brevern started her career in the biotech industry in 1998 joining PharmaLex in 2013. Within the Global Program Management she has driven the strategic set-up and implementation of new large volume programs as well as the oversight of established programs.
    Paula King

    Paula King

    REGULATORY DIRECTOR AT PHARMALEX
    Paula has worked in the pharmaceutical industry for over 20 years in a variety of Regulatory, Quality and Compliance Roles. She joined PharmaLex in 2020 , in this role Paula lead leads a team of Regulatory and Project Management professionals supporting across a wide range of client activities.

    Related Services

    PharmaLex’s Global Statistics and Data Science team brings together a wide range of experts – from study design and planning to statistical analysis, reporting and data management. Our experts help companies with complex innovative trial design, translational and precision medicine, pharmacometrics, and data science across the clinical journey.

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    With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.

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    CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

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    We have been providing Commissioning, Qualification, and Validation (CQV) services to our clients for over 18 years. Our dedicated CQV professionals bring a depth of knowledge across the entire validation lifecycle (VLC), having supported clients from all major sectors within the Life Sciences industry. We guide our clients in the selection of the right CQV strategy and fully support all deliverables, from protocol preparation, through “on the floor executions” data analysis and Report preparation.

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    Place your Pharmacovigilance, Epidemiology, and Risk management activities (PER) in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire PER processes – our knowledgeable experts will be there for you no matter where you are.

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    The collection and processing of ICSRs are the most basic and important aspects of Pharmacovigilance system. PharmaLex delivers end-to-end ICSR Management solutions through our experts and services. Contact our specialists to tailor a service plan Contact Us ICSR (Individual Safety Case Report) Management PharmaLex offer the full range of ICSR Management Services from collection, triage, Data Entry ,Quality Review and Medical Review for regulatory submission of ICSRs.PharmaLex provide Safety Case Management services in various therapeutics areas and products in Pharmaceuticals, Radiopharmaceuticals, Nutraceuticals, Cosmetovigilance, Materiovigilance, Biologics / Biosimilars etc. : End-to-end Safety Case management Individual Case Study Report (ICSR) plays an

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    We offer a modular, end-to-end approach to literature surveillance for pharmacovigilance and our experts are flexible enough to offer a tailored solution as well accordingly to client’s requirement.

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    PharmaLex customizes the signal management activities as per client requirements ensuring reliable, high quality, trackable data in compliance with the regulatory guidelines (e.g., GVP Module IX & FDA Good Pharmacovigilance Practice and Pharmacoepidemiologic Assessment). In addition to Signal management services, our team of experts are also experienced and well versed in providing responses to safety questions from the Health authorities by providing strategic advice on the approach to respond to the HA query; evaluating and critically appraising ICSRs, aggregate data, and literature and thereby providing a comprehensive evaluation report considering the strengths and weaknesses of all the data sets and sources reviewed.

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    PharmaLex’s organization ensures global delivery of all PV audit services. We are the first-choice provider of PV audit services for many pharmaceutical companies around the world. At PharmaLex, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.

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    Being a global company with an extensive geographical reach, thus far, PharmaLex can carry out these evaluations in Europe, Australia, Canada and US.

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    If required, PharmaLex can take on the tasks and responsibilities of the EU Qualified Person Responsible for Pharmacovigilance, or provide a deputy in times of absence or illness.

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    PharmaLex can provide support with PQS planning, development and implementation. We can also remediate PQS that are not working properly and we can also provide support with the implementation or remediation of specific elements of the PQS such as Supplier management, Quality Risk Management, Change Management, Learning Management and deviation management to name a few. We can design and implement PQS for MIA, WDA and MAH.

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    PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.

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    Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market.

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    Global Approach

    PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

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