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.
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—to establish 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 work force and innovative solutions infuse long-term value into every level of your business.
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.
Meet the Team
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 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.
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.
Client and patient focused Pharmacist, with solid educational foundation and background in Pharma products, Nutritionals and Cosmetics. In Pharmaceutical industry since 2007, with wide experience in different areas including production, regulatory affairs, and quality assurance. In Pharmalex since 2017, supporting global projects and programs and recently as Global Program Manager.
Services At A Glance
The Pros of Portfolio Maintenance Outsourcing
Managing and supporting a product’s lifecycle requires operational excellence. Whether you’re starting development, entering clinical trials, navigating Marketing Authorization Application (MAA) / New Drug Application (NDA) submissions, or actively maintaining compliance—there are a lot of moving parts that require constant attention.
Today, the development and marketing of pharmaceuticals is a highly complex undertaking, not only involving several distinct disciplines, work streams and procedures but often also covering multiple countries or regions. The economic success of pharmaceutical companies heavily depends on their ability to take the right decisions regarding their marketing strategy and how they transform their vision into efficient operations.
Introducing a new drug to market requires a complex interplay of multiple activities and disciplines. For a successful launch, drug developers need a partner that offers holistic solutions and collaborative expertise to help them overcome rising R&D costs and growing regulatory complexities. That’s where a foresighted approach, such as Integrated Product Development (IPD), can make the difference.
Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to:
- Increase market share by consolidating their product portfolio into specific therapeutic areas
- Replenish their previously dwindling product pipeline
- Enter into emerging markets with existing and new products
- Reduce costs through the consolidation of manufacturing sites
After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.
To retain Marketing Authorization, the MA holder must continually:
- Update work to ensure the approved dossier is valid
- Address safety surveillance issues by having pharmacovigilance systems in place
- Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
- Respond to renewal requirements, as necessary
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.
In the past, market access for a medicine depended almost exclusively on efficacy and safety. These factors are still critical, but today, clinical differentiation and its effects on healthcare outcomes and resource utilization / optimization require more comprehensive approaches. Today, more than ever, pharmaceutical companies must demonstrate how a new drug improves patient outcomes, reduces the burden of the healthcare system as a whole and is worth its price. To satisfy these criteria, pharmaceutical manufacturers have gradually expanded their strategies ‘beyond the pill’ to build initiatives that take a more holistic view of patient treatment, provide better real-life evidence and therefore a stronger value proposition for decision makers.
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.
Ensuring regulatory success
Meetings with Health Authorities such as the FDA in the US, the EMA in Europe or other major Health Authorities worldwide have shown to increase the probability of market approval and can have a most favorable impact on development times and costs. Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication and to hold face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority?
Health authorities around the world mandate drug companies with various Drug labeling formats and standards. Product Labeling is a complex process that is highly affected by a constantly changing regulatory environment. A mistake in product labeling or bad readability can come at a high cost, which is why often times companies seek external support. In order to adhere to the legislation, product information related to manufacturing, safety and efficacy included in product labels, should be controlled by maintaining a central Company Core Data Sheet (CCDS). We provide end-to-end support for the entire labeling process, which includes managing global and regional requirements, compliance, technology requirements, as well as proof-reading and translation services.
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing.
Modern Regulatory Operations is about proactively implementing efficient information management, scalable operational excellence, and innovative digital solutions like regulatory automation.
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.
Comprehensive toxicology services
Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data into the right context of patient exposure (dose) it informs whether patient safety is unlikely to be compromised and therefore the likelihood of regulatory acceptance. This is the foundation of toxicological risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualifications and experience.
The marketing authorization applicant/ holder shall have the necessary means to fulfil the tasks and responsibilities listed in EU Directive 2001/83/EC as amended by EU Directive 2010/84/EU.
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. Key tasks of the EU-QPPV comprises:
- Ongoing monitoring of the benefit and risks of medicinal products.
- Maintenance of the Pharmacovigilance System Master File.
- Serving as point of contact to Regulatory Authorities with 24 hours availability.
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. 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
- Cases Reconciliation
- SmartPHLEX solutions and Safety Databases
PharmaLex recognizes that medical and scientific literature emerges as a critical information source for benefit-risk evaluation of medicinal products. PharmaLex offers 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.
Global (Indexed) & Local (Non-Indexed) literature surveillance becomes an integral aspect in pharmacovigilance as the main objective of the screening is to identify case reports (ICSRs) and/or any substantially new information from studies (epidemiological, clinical, and non-clinical) pertaining to safety and efficacy. Literature search and review is therefore a critical activity that we undertake for the safety profiling of drugs.
Marketing Authorization Holders need to fulfil their responsibilities to perform regular risk-based audit(s) of their pharmacovigilance system (i.e. auditing of their affiliates and partners). In addition, vendor qualification audits need to be conducted on demand.
Our Pharmacovigilance audits obtain evidence and evaluate the evidence objectively to determine the extent to which the audit criteria are fulfilled and contribute to corrective and preventative actions (CAPA) ensure the improvement of risk management, control, and governance processes.
We apply our broad and long-term experience, as well as global network to fulfil the requested support regarding the planning Pharmacovigilance audits at various levels (strategic, tactical, and operational).
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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