Global Headquarter / End-to-end Outsourcing
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.
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.More Info
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.More Info
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.More Info
Commissioning, Qualification and Validation
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.More Info
Gap Analysis and Consulting
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.More Info
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 anMore Info
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.More Info
Monitoring and Signal Detection
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.More Info
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.More Info
Pricing and Reimbursement
Being a global company with an extensive geographical reach, thus far, PharmaLex can carry out these evaluations in Europe, Australia, Canada and US.More Info
Qualified Person for Pharmacovigilance (QPPV)
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.More Info
Quality Systems and Compliance
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.More Info
Regulatory Writing / Scientific and Technical Writing
PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.More Info
Toxicological Services and Risk Assessment
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.More Info
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PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.