Innovations to Market
Plan early for better outcomes
From discovery to post-launch activities, and every point in between, there is a pressing need for expertise to accelerate speed to market and achieve better outcomes. Together, PharmaLex and Cencora offer end-to-end support across the product commercialization journey, including global market access strategy and execution.
In today’s complex global landscape, the earlier a company can start planning, the better the chances of easing the financial burden, reducing risk, navigating the regulatory process, and accelerating time-to-commercialization.
The power of joint solutions
PharmaLex complements Cencora´s existing suite of services, guiding clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities.
• Specialty pharma, cell and gene, and biosimilars
• Global scientific, regulatory, safety, quality and market access solutions
• Third-party logistics and specialty logistics around the world
• The flexibility and expertise to innovate to address unique product needs
Guiding the decision-making process
At each stage of the development process, there are decision points that affect a product’s chances of success. With so much at stake, companies need to make sure they are planning, preparing and optimizing processes.
Good preparation begins with an assessment of potential risks, the most time- and resource-consuming activities, and how technology might be leveraged at each phase.
When the process moves into the planning phase, key questions arise, such as: Do you have product available in sufficient quality and quantity for preclinical studies? Do you have a GxP strategy that will meet regulatory requirements in each market? Are your preclinical data, your quality, and pharmacovigilance set up sufficiently well to support moving to human studies?
Once the clinical trial phase is well underway, it’s important to scale the process and consider what will be needed to gain marketing authorization in key markets, the market sequence, any third-party logistics that will be required, and an environmental monitoring program.
Finally, accelerate this process by carefully considering the distribution strategy, any cold-chain or other special handling issues that might impact the supply chain, and what data and insights might be key to understanding adoption and access patterns.
How we accelerate your performance
PharmaLex streamlines the transition of responsibilities via steering committees and a governance structure that aligns with client operations. Our deep knowledge of local markets and ready access to resources ensures global and local requirements are understood and met through agile management and roll out of services in new and emerging markets. All this expertise is supported by a suite of enabling technologies that help to automate processes and bridge silos between functions and local affiliates.
Innovations to Market 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).More Info
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
Clinical Development Services
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. This includes software for management of trial master files, resources for day-to-day processing of trial content and associated expert consultancy through one of the PharmaLex family of companies.More Info
Clinical Trial Applications
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.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
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.More Info
eCTD, System Operations and Data Management
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.More Info
Gap Analysis and Consulting
Place your Pharmacovigilance, Epidemiology, Risk management (PER) and Document Management activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire processes – our knowledgeable experts will be there for you no matter where you are. Expertise extends to Clinical document management (e.g. TMFs) and Regulatory document management (e.g. submissions, RIM, xEVMPD, IDMP) through one of the PharmaLex family of companies.More 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
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
Promotional Materials & Compliance
Pharmalex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. We will advise on and review activities and processes for healthcare compliance that fall …More Info
Our product offerings are considered highly innovative in the industry for their out-of-the-box best practices capabilities, use of automation technology, and user-focused design.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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