Integrated Product Development

PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the FDA, 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).

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.

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.

Clinical trials play a crucial part in any drug development life cycle where it is key to gain information on a product’s safety profile. The PharmaLex international team of clinical safety experts, with large expierence in the management of clinical safety activities, effectively supports sponsors with Pharmacovigilance activities during clinical trial development programmes. PharmaLex designs […]

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.

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.

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.

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.

To achieve an effective patient access to the innovation, the product must demonstrate value to the funder, the payer, the clinicial, and the patient. We develop different types of health economic models from Early-Phase to highly complex. Demonstrate the economic value.

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.

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

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

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.