Outsourcing Services to Support Local Affiliates

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    Local affiliate services help pharma companies stay competitive, flexible and innovative

    Pharmaceutical companies are struggling to navigate an increasingly complex global reimbursement and regulatory environment. The challenges are amplified at large pharma businesses, which can have as many as 100 operating companies and affiliates all over the world and must manage these with varying levels of expertise and resources.

    PharmaLex supports local affiliate needs with a model tailored to specific needs and operating models, ensuring safety and compliance while continuing to meet ever-changing payer and regulatory demands. PharmaLex’s experts work across scientific and medical affairs, quality and compliance, regulatory affairs, and pharmacovigilance and across many different regions. Our services deliver workforce flexibility, streamline processes, and help fill gaps in local knowledge.

    Cross-functional expertise, broad global reach

    PharmaLex’s experts can support your product’s full lifecycle – from pre-submission to post-approval — and manage the entire maintenance of the mature portfolio. With coverage in markets globally, our teams can provide local on-the-ground support and act as an extension for your global development teams.

    Centrally managed and geographically dispersed, PharmaLex’s flexible model is designed to ensure efficiency and compliance and support more effective local decision-making. It ensures access to skilled resources with expertise in local activities while also benefiting from the scalability, transparency and standardization required to maintain regulatory compliance.

    In-market expert teams

    Our local experts recognize that successful partnerships start with solid understanding of local regulations and requirements, while aligning with our clients’ goals, reporting structures and key performance indicators.

    With an understanding of the cultural nuances, language, and technical requirements from each health authority, PharmaLex helps you to break down functional and geographic silos.

    Your affiliate locations, our market coverage

    From North America to Europe, the Middle East, Asia, Africa, Commonwealth of Independent States (CIS) and emerging markets in Latin America (LATAM) such as Brazil and Mexico, PharmaLex delivers centrally managed services at the regional and local affiliate level. This helps to harmonize processes, ensure compliance and drive greater efficiencies through PharmaLex’s robust technology platform and global infrastructure.

    Local Affiliate Services

    PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).

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    PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs.

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    PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.

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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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    Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development strategies needed.

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    Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.

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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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    Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.

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    Our GxP Technical Consulting Service provides access to our international Consulting Team, including a number of former EU and US Regulators, with expertise across the entire product lifecycle, ensuring that the broad Regulatory perspective is factored into the detailed consideration of your query

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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, …

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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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    The key to unlocking market access, is the ability to look beyond the science, to understand the market dynamics that will shape the future and drive value. To gain market access in pharma and remain competitive, pharmaceutical and medical technology manufacturers must be able to demonstrate clinical and economic evidence to providers, healthcare decision-makers and payers.

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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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    Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.

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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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    Global Approach

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

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