Welcome to the Population Approach Group in Europe

Amador Bioscience: offers advanced simulation and modeling services to optimize the safety and efficacy of clinical trials, including noncompartmental PK/TK analysis, translational modeling, toxicokinetics, population pharmacokinetics, and clinical modeling and simulation. With our extensive experience and expertise, we assist in meeting regulatory standards, making go/no-go decisions faster, and accelerating drug development. We also provide global drug development and launch support, offering access to multiple markets and helping navigate region-specific requirements.
BAST Inc Limited: is a consulting business that was founded in 1991 with the purpose to provide population PK analysis to the pharmaceutical industry. We have widened our services considerably since 2010. Now we offer, in addition to standard popPKPD services, risk and utility assessments through mechanistic modelling. Our quantitative decision support adds value to projects of biotech companies in search of additional venture capital.
Calvagone: A new name with familiar faces. At Calvagone we provide model-based consulting services with the aim to quantify drug, disease and trial information and to aid clients in efficient drug development and regulatory decisions. Our team consists of consultants with a wide experience in programming, mathematics, pharmacology, pharmacometrics and drug development, and a strong commitment to support clients at each step of the drug development process with a fitted and timely approach that will address key development questions and result in an optimal understanding of clinical trial results.
Certara Strategic Consulting: Now the largest and most comprehensive model-based drug development and strategic pharmacometrics organization, Certara Strategic Consulting brings together the resources of Certara’s leading consulting group, Pharsight Consulting Services (PCS) with scientific powerhouse Quantitative Solutions Inc. The newly formed Certara® Strategic Consulting delivers value by integrating advanced modeling and simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key modeling and simulation projects on behalf of hundreds of biopharm companies, Certara Strategic Consulting brings its track record of success and a broad range of expertise to each assignment. Our team of more than 70 scientists, consultants and industry professionals can strengthen both your pharmacometric capacity and capabilities to quantitatively inform internal decisions and improve the probability of success of regulatory interactions. We can provide you with additional resources and specific expertise to support you along the full value chain from data-management, to analysis and interpretation and subsequent integration in reporting and filings.

DruDevO: With 20+ years of experience in modeling and simulation we specialize in consultancy for DRUg DEVelopment Optimization using M&S methods. Based on the experience in this field we have also developed a time saving NONMEM interface which also links Windows to Linux/Mosix systems. We comply with GCP and 21 CRF 11 guidelines.
Dynakin: is the sole one-stop integral provider of support in drug development, in-house, from GLP biolab to M&S pivotal strategic consulting and from GCP clinical trial to regulatory application all driven by a MBDD translational method. Dynakin’s M&S expertise applies industry standard M&S and metadata analysis within a strictly “Good Modeling Practices” environment of custom scripting and traceability. Dynakin presented the first model based PIP (EMA) and continues to participate in numerous projects for its customers faced with agencies around the world, including most of Europe, the FDA and Japan. The company also integrates a grounds up scientific software development department with a main product line of maximum likelihood and Bayesian modeling software, DynaPred®. Through its offices in Spain, Canada, France and the US, Dynakin successfully addresses complex tight timeline projects.
esqLABS: is a CRO providing consulting for physiologically-based pharmacokinetics/pharmacodynamics (PBPK/PD) modeling and simulation with, and contract software development for, the Open Systems Pharmacology Suite (OSP Suite with PK-Sim® and MoBi®). esqLABS is an active member and strong supporter of the OSP community. The esqLABS portfolio includes standard PBPK applications, development of sophisticated Quantitative Systems Pharmacology disease platforms (e.g. the Diabetes Platform), and training on PBPK and QSP with the OSP Suite.
ICON Clinical Research LLC: is committed to providing the most advanced analysis methods and tools for the pharmaceutical industry through continued enhancements to the NONMEM® software, the industry standard for population pharmacokinetic/ pharmacodynamics analysis; ensuring pharmaceutical companies may continue to use this trusted analysis tool, incorporating classical as well as new analysis algorithms for present day pharmaceutical development. In addition, PDx-Pop®, a graphical interface working in concert with NONMEM®, integrates with existing tools and its own automated methods to expedite the population modeling and analysis, providing optimal flexibility and increased efficiency and functionality.
InSysBio: is one of the pioneers in Quantitative System Pharmacology (QSP) modeling for drug research and development and has been providing services for more than 10 years. Our team continuously improves methods and tools for biological modeling and develops QSP platforms and software infrastructure. Innovative approach applied by InSysBio has already become a part of the drug development process implemented by our strategic partners. Nowadays there are more than 100 completed projects in collaboration with leaders of pharmaceutical industry in various therapeutic areas including Immuno-Oncology, Neuroscience, Inflammation and Immunology, Infectious and Rare diseases. Moreover, the InSysBio team provides educational assistance to academic entities.
IntiQuan: is a consulting company providing services and solutions for impactful model-informed drug development. We partner with pharmacometrics organizations, biotechs and investors to extend their resources, provide quantitative expertise and leverage the power of data for better decision making. We are proactive about improving the efficiency and quality of daily scientific work, and we share our solutions with customers and the community. Our clients tell us that they appreciate how our deliverables are self-sufficient, fully reproducible and performed in the most efficient manner. Our team has an extensive experience from big pharma, biotechs and academia, and strong technical background in pharmacometrics, general modeling & simulation, systems biology, medicine and physics.
Kinesis Pharma: aims to facilitate a fast and high quality development and registration process for medicinal products through consultancy and contract research services. Kinesis’ PK/PD modeling services include: exploratory analysis for instant decision-making (e.g. dose selection and trial design), meta-analysis and model-based extrapolations. Model based extrapolations include animal to human or adult to paediatric extrapolations for dose selection and answering “What if” questions. At Kinesis-Pharma the model is not a goal in itself, but a tool to provide the answers you seek.
The Laboratory of Applied Pharmacokinetics and Bioinformatics (LAPKB): is a pharmacometric resource for optimal study and control of pharmacokinetic/pharmacodynamic systems and for individualized drug therapy and personalized medicine. Our research activities include: application of stochastic control theory to the design of optimal dosage regimens; improved methods for population pharmacokinetic modeling; investigation of process and measurement noise in the clinical environment; evaluation of alternative parameterizations of pharmacokinetic models; optimal monitoring strategies for pharmacokinetic studies, and clinical trials. We produce two freely available software tools: 1) Pmetrics - a non-parametric and parametric population modeling and simulation package for R; 2) BestDose - a Windows executable program for multiple-model Bayesian adaptive control of individual patient therapeutic drug dosing to achieve target concentrations with maximum accuracy and precision. An R package for BestDose is available by special request.
LAP&P Consultants: provides interdisciplinary support on advanced pharmacokinetic and pharmacodynamic analyses to solve complex problems in preclinical and clinical drug development. LAP&P has a professional infrastructure for advanced PK/PD analyses and reporting for the pharmaceutical industry, based on the most recent developments in academic science. Services include Mixed Effect (population) analysis, Physiologically Based Pharmacokinetic (PB-PK) Modelling, disease progression analysis and clinical trial simulations.
LYO-X: is a consulting and service company specialised in Systems Pharmacology. Our unique focus is the preclinical and clinical development of biologics. We have extensive experience in all development aspects which are unique to this class of drugs, such as PK/PD properties, target mediated disposition, optimal dose and regimen selection, MABEL and first in human dose selection. Supported formats include mAb, Fab, scFv, bi-specifics, ADC, fusion proteins, siRNA and cell based therapies. Our customers are both global pharmaceutical companies and small biotechnology companies working with highly innovative products. LYO-X is part of the Integrated Biologix (iBx) Network, a strategic partnership with Integrated Biologix Gmbh and KinDyn Consulting Ltd. The iBx Network has senior experts dedicated to biologics modelling, preclinical toxicology, assay development, PK/PD interpretation and clinical pharmacology.
Mango Solutions Ltd: is a UK based data analysis company. Operating globally, we assist our customers in a number of different markets by delivering high performance data analysis solutions. Mango Solutions can help you to embed the power of sometimes complex statistical analysis directly into the decision making process; turning data into powerful information to support business decisions and putting powerful analysis tools into the hands of end users. Working professionally and effectively, we are happy to engage in a variety of work- from data analysis training to application development - meeting your specific needs.
Metrum Research Group LLC: provides contract services aimed at enhancing biomedical R&D through quantitative modeling and simulation. Our collaborations with pharma/biotech industries are characterized by cutting-edge science, transfer of knowledge, quality deliverables and innovative, strategic application of M&S technologies. MetrumRG employs a full-time scientific staff with extensive experience in quantitative M&S. Our work is performed in and managed under quality assurance systems and our secured, managed computing infrastructure provides continuous and robust support for critical client projects.
Model Answers: is a well established pharmacometric consulting company that provides services to a global client network. The team delivers a range of highly innovative solutions with an emphasis on quality, transparency and reproducibility. With live project mapping, interim results management, sophisticated operating procedures and reporting systems, clients can trust Model Answers to deliver a superior product on time.
Occams: provides high-quality strategic services to clients in the pharmaceutical industry. We derive our name from the principle known as Occam’s razor: when multiple explanations are equally capable of describing the outcome, the least complex solution is preferred. Make no mistake: we deliver complex state-of-the-art modelling, but our many years of experience in academia, regulatory agencies, industry, at CROs, and in providing consultancy services to the pharmaceutical industry have honed our ability to ask and answer the key questions in drug development clearly and efficiently without being distracted by side issues.
Parexel: offers wide expertise in clinical PK/PD, pharmacometrics, and model-informed drug discovery and development (MID3) across all clinical phases from translational sciences for First- Time-in-Human (FTIH) studies to marketed products. Parexel pharmacometricians and clinical pharmacologists who are based around the world offer seamless integration of services across numerous therapeutic indications, and provide expertise in the strategic implementation of modeling & simulation services to driving drug development decision-making. These offerings allow our experts to help clients to optimize the time and cost of bringing drugs to market. We are committed to delivering the highest quality service and meeting all aspects of regulatory compliance.
PD-value: specializes in translational PK-PD services. PD-values believe in getting more value out of your data using biomarkers, the value of PD. With more 15+ years of experience in both research/discovery and clinical development teams, from lead finding to registration, an unique perspective is offered in terms of modeling and simulation technical expertise, but also in strategic development consultancy. Clinical and research activities are supported by translation from animal to man, and from healthy to diseased, with a focus an integrated decision making and always with an eye for adding value to your projects!
PharmacoMetrica: is a global pharmacometrics consulting company. We develop and apply a Model Based Drug Development approach to address key and strategic questions in drug development such as the evaluation of exposure-response, dose selection, trial design, in-licensing drug evaluation, disease progression, model-based meta-analysis of therapeutic area data, physiologically-based modeling and clinical trial simulation to support decision making and trial design evaluation.
Pharmetheus: offers consulting services with emphasis on the application of pharmacometric approaches to support drug development decisions. The company was founded in 2012 in Uppsala, Sweden, as a spin-off to the Pharmacometrics Research Group at Uppsala University. Pharmetheus provides strategic advice and technical expertise in most therapeutic areas and focuses on delivery of on-time, high quality work according to the latest regulatory guidelines. The team of consultants and advisors, with wide experience in the area of Model Based Drug Development, is dedicated to developing fit-for-purpose models and analyses to answer the research questions of our clients.
PhinC Development: is a services company specializing in the early phase development of candidate drugs. It offers two types of research services. The first type is "integrated" operational support for biotech company R&D teams, providing them with all the tools (methodological, scientific and regulatory) to hand to make informed decisions and thereby effectively design their development plan. The second is carrying out statistical and pharmacometrics analyses (MBDD principle, Model-Based Drug Development), with the goal of getting the most from the key development steps and allowing time and money savings.
Projections Research, Inc.: provides a wide range of Study Design (D-optimization), Pharmacokinetic, Pharmacodynamic, and Pharmacometric services performed by internationally recognized experts with experience working within industry, academia, and FDA. The PRI team analyzes clinical trial data and provides clear concise reports allowing faster, better informed decision-making during the drug development process and ensuring fewer queries during the regulatory review process.
Probayes: provide ProBT© which is a powerful modeling, inference, and learning platform inheriting 10 years of experience in the domain of Bayesian probabilistic computing, and ProBT-XL which makes Bayesian models prototyping and testing easier and quicker. It provides a Microsoft Excel graphical user interface to ProBT. Use it to design Bayesian networks while taking advantage of the worksheet environment and the Bayesian programming approach.
Pumas AI: Working as an integral part of our client’s team, we at Pumas-AI navigate a rapidly evolving drug development and regulatory landscape with our multidisciplinary expertise across the length and breadth of the pharmaceutical industry. From scientific modeling and simulation services to regulatory strategy and submissions, we work with our clients in different capacities at any or all stages of their drug development process. With over three decades of experience in pharmaceutical research, development and regulation, our experts approach challenges and opportunities across the drug development lifecycle from multiple critical standpoints, enabling 360° insight. We map out the most efficient route from discovery to delivery, unearthing hidden insight along the way. Our team has extensive experience in the drug development regulatory sector, contributing to 400+ regulatory submissions and policy research.
qPharmetra: provides efficient, effective, and decision-focused pharmacometric consulting services to Pharma and Biotechnology organizations. Our experienced, senior modeling team performs a comprehensive range of analyses in support of all phases of drug development, including population PK, PK/PD, clinical trial simulation, clinical utility analysis and reporting. Further, we have standardized and automated our work processes from initial project preparation through final project documentation. The result: efficiently generated reports and presentations providing clear guidance to internal and external stakeholders in the drug development process.
QuantPharm LLC: is a consulting company located in Maryland, US. It specializes in development and application of advanced mathematical modeling, simulation, and data mining methods to support pharmaceutical and biotechnology industries. QuantPharmTM offers fast, efficient and high quality population analysis of pharmacokinetic and pharmacodynamic data and model-based clinical trial simulations to support all stages of drug development, from pre-clinical to Phase IV.
Rosa & Co. LLC: Drug development research using customized, focused drug-disease simulation platforms (PhysioPD™ Research). This research complements the expertise and experience of researchers and clinicians, guides more effective experimental and trial design, and enables deeper understanding of empirical data. PhysioPD Research enables dramatically more effective learning about the connection of drug and disease mechanisms to relevant preclinical and clinical outcomes and supports more confident decisions at all stages in research and development.
Rudraya: is a Scientific Platform and Information Technology Service provider to Pharmaceutical, Biotechnology, and Healthcare organizations with core focus on High Performance Computing Platform (local or cloud based) and Clinical Outcomes Databases Platform (KEEP - Knowledge Enhancing and Enabling Platform). Rudraya is strategically located in both the US (New Jersey and Boston) and Europe (Basel) to provide services and support to global clients. Rudraya’s cloud based, regulatory compliant, and validated computing platform provides economical, flexible, and agile environment for Pharmacometrics, Genomics, Biostatistics, and Translational Medicine needs. Rudraya’s KEEP Enterprise aims to integrate and enhance clinical knowledge and enable model-based meta-analysis (MBMA) by providing the capability to quickly and securely access, share, explore, and analyze comprehensive, integrated, up-to-date clinical efficacy and safety data.
Shafi Consultancy Ltd: is a SAS programming group specialising in producing NONMEM ready files using raw data from clinical trial databases. We have 10 years of experience in producing datasets both for PK/PD analysis and for analysis using NONMEM. Using our extensive expertise, client specific standard process are established to handle missing and dirty data, to merge different types of covariates and to produce traceability and summary tables. This ensures datasets can be produced quickly and consistently in a timely manner for analysis.

Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide.
Vantage Research: provides Quantitative Systems Pharmacology (QSP) Consulting and Services. With a multidisciplinary scientific staff comprising of model development engineers, and biologists with deep experience in the life sciences areas, Vantage caters to BioPharma R&D teams that look for model informed decision making approaches to take critical decisions at various stages of drug development lifecycle. We are proudly associated with several global BioPharma companies, spanning a variety of therapeutic areas including Diabetes, Immuno-Oncology, AutoImmune Disorders, Hypertension, Anaemia, Sepsis and Opthalmology.

Please send comments, requests for changes or additions and other questions related to this list to i nfo@page-meeting.org .