AMS has been a competent partner to our clients in the pharmaceutical and healthcare industry for over 25 years. We use our many years of experience at the national and international level to ensure the best possible development and establishment of your drug or medical device. Our expertise is available to you for all processes – from the clinical development of your product, through its benefit assessment and the subsequent reimbursement negotiations, to sales and marketing, as well as pharmacovigilance and data collection accompanying the application.
Our interdisciplinary teams focus on individual and efficient solutions to successfully bring your product to market maturity and sales.
Benefit from the experience, expertise and enthusiasm of our experts.
Our entire AMS team relies on professional and appreciative cooperation and a high degree of diligence and reliability in all areas.
Global Services & Solutions
Customize your service package to align with your unique requirements.
Your success, our priority – all services from a single source
Take advantage of our seamlessly integrated services: short communication paths, quick decisions, and perfectly coordinated processes. We offer not only solutions for individual or combined services but also comprehensive support throughout the entire development and commercialization process.
From clinical development and benefit assessments to reimbursement negotiations, sales, marketing, as well as accompanying pharmacovigilance and data collection – we are your reliable partner at every stage.
Whether you're a start-up or a global enterprise, benefit from our strategic consulting and cross-industry expertise from the very beginning. We’ll partner with you to make your product a market success.
Drug Development, Full Service & Modular
Phase I-III Clinical Trials
The AMS Clinical Research team combines global reach with local expertise to flexibly meet the specific requirements of your clinical development programs. As a full-service Clinical Research Organization, we offer comprehensive services, from early concept consultancy to the final Clinical Study Report. Our specialized teams cover all essential areas, including Clinical Operations, Regulatory Affairs, Medical Writing, Data Management, Biostatistics, and Clinical Safety, ensuring the success of your Clinical Trial.
Drug Development, Full Service & Modular
Pharmacovigilance & (EU-)QPPV
Pharmacovigilance (PV) is an essential component of the healthcare industry, ensuring the safety and efficacy of medicinal products throughout their lifecycle. It involves the collection, assessment, monitoring, and prevention of adverse effects and other drug-related problems.
The Qualified Person for Pharmacovigilance (QPPV) plays a central role in this process by overseeing all PV activities and ensuring compliance with legal requirements.
Our PV and QPPV services support pharmaceutical companies in meeting these critical obligations and maintaining the highest standards of patient safety and regulatory adherence.
Medical Devices
Clinical Investigations
Clinical Investigations in the complex world
of Clinical Evaluation is a not a simple issue.
AMS is specialized in helping you navigate the complex requirements and conducting clinical investigations effectively. From early feasibility studies to extended pivotal studies we offer comprehensive support throughout the process.
Medical Devices
In-vitro Diagnostics
AMS specializes in assisting you in discerning the imperative for Clinical Performance Studies for In-vitro diagnostics. With extensive experience conducting these studies on an international scale, we offer consultancy services to navigate regulatory requirements, Clinical Safety and Vigilance for your IVD.
Market Access in Europe
Pricing & Reimbursement
With the GKV Financial Stabilization Act (GKV-FinStG), which came into force in Germany in 2023, the legal framework for negotiating reimbursement prices has become significantly more complex. Further legislative changes are to be expected in the coming months and years.
In this dynamic environment, it is important for pharmaceutical manufacturers, with regards to negotiating the reimbursement price, to pursue the optimal strategy from the very beginning of the AMNOG process. Our Pricing-Team is your competent and reliable partner for every step - from the extensive analysis of the reimbursement price to strategic and formal preparation for arbitration procedures.
Market Access in Europe
Methods Assessment
The requirements for the conformity assessment of medical devices have significantly increased with the Medical Device Regulation (MDR) and the current MEDDEV guidelines. For manufacturers, this means greater effort, more complex processes, and higher regulatory hurdles. But even after achieving CE marking, one crucial question remains: How do you successfully bring your product to market?
Marketing & Training
Training & Education, General Individual
Our extensive experience in e-learning and our wide range of courses make us your ideal partner for professional development in the pharmaceutical industry. Benefit from our expertise and join the ranks of our many successful graduates, such as Certified Pharmaceutical Representatives (IHK) and Medical Science Liaison Managers (MSLM).
As an employer, take advantage of our offer to develop and promote your employees.
Marketing & Training
Marketing & Sales
We have been successfully supporting healthcare companies in marketing their products for over 25 years. Our services range from sales and marketing consulting to the implementing of pilot projects, recruiting and managing entire sales teams and marketing complete product lines.
Drug Development, Full Service & Modular
Phase IV Clinical Studies
The specific requirements of late-stage clinical research are often underestimated. At AMS Clinical Research,we are pioneers and market leaders in Non-Interventional Studies, Post-Authorization Safety Studies, and Evidence Generation Studies, backed by exceptional experience.
We offer tailored processes and tools to meet the unique needs of late-stage clinical programs. As a full-service Clinical Research Organization, we provide comprehensive services from early concept consultancy to the final Clinical Study Report.
Medical Devices
Post Marketing Clinical Follow-Up
AMS specializes in conducting Post-Market Clinical Follow-up (PMCF) studies in alignment with national legislations, good clinical practice standards, and requests by notified bodies. Allow us to assist you in executing a comprehensive PMCF study for your Medical Device, ensuring ongoing compliance and enhanced patient safety.
Medical Apps / DiGA
Digital Health Applications (DiGA)
Do you need help with clinical investigations, CE certification, Fast-Track Procedure or distribution
of your Digital Health Application (DiGA)?
Let us support you with our expertise and experience!
Since 2020, right from the very beginning of the Fast-Track Procedure, we at AMS have been supporting and advising clients from app manufactures and start-ups to pharmaceutical companies in various steps of the lifecycle management of DiGA.
Market Access in Europe
EU HTA
Since 2015, AMS has actively shaped the EU HTA process through regular contributions at conferences, participation in EUnetHTA events, and as a member of EUCOPE.
Our practical experience and profound expertise will ensure that you are well-prepared and guided through the EU HTA process.
Market Access in Europe
HTA Statistics
We provide comprehensive consulting and support on all aspects of evidence generation, statistical analysis, and results presentation for EU and national HTA. Our goal is to strategically align with HTA requirements while shaping your evidence base to achieve the best possible outcomes.
To ensure your evidence is impactful, we apply a broad range of advanced statistical methods tailored to your specific needs.
Market Access in Europe
Routine Practice Data Collection
We bring extensive firsthand experience from actively engaging in multiple AbD procedures.
Our services include strategic consultation, individually tailored workshops, active participation during the stakeholder participation process and preparation of study documents including study protocols and SAP. Our interdisciplinary
teams are specialized in biostatistics, medical writing, project management, and clinical operations. With our hands-on experience and multidisciplinary approach, we provide comprehensive support and guidance throughout your entire AbD process - from strategic planning to implementing the AbD.
Market Access in Europe
AMNOG Benefit Assessment
Starting as pioneers in 2010, AMS is now one of the market leaders in the field of AMNOG benefit assessment. Our interdisciplinary team of medical writers, statisticians and project managers accompanies you professionally through the entire benefit assessment process – covering everything from early G-BA consultations to oral hearing simulations.
Marketing & Training
Recruitment, Staffing & Leasing
As part of our Marketing & Sales services, we have extensive experience in recruiting professionals and executives, placement services, and temporary staffing, particularly in the healthcare sector. This also includes providing entire sales teams.
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