Regulatory Affairs
Whether it’s a clinical trial or a medicinal product – we cover all areas for approval.
STEADILY WORKING ON THE FUTURE OF HEALTH
STEADILY WORKING ON THE FUTURE OF HEALTH Medicinal Products & Medical Devices Clinical Research & Phase I–IV Trials Data Management & eCRF Design Regulatory Affairs & eCTD Management Product Development & Consulting Pharmacovigilance & Risk Management Medical Writing & Expert Reports
Mediconomics provides spot‑on professional CRO services.
Mediconomics is a successful CRO and pharma consultant and provides services for research and development projects of both Medicinal Products and Medical Devices.
Headquartered in Hannover, Germany and with subsidiaries in Denmark, Switzerland, the UK and US, Mediconomics operates internationally. All activities are compliant with the relevant guidelines in the ever changing regulatory environment.
With Quality Management being one of our foundations of success, all members of our interdisciplinary team are not only trained continuously to the latest standards, but we also maintain a certified Quality Management System acc. to DIN EN ISO 9001:2015
The core philosophy, derived from more than 20 years in successful client relationships, is to keep the company small enough to provide flexible, bespoke solutions but large enough to deal with complex situations.
Since 1999, our systematic and tailor-made approach has earned us an excellent reputation, and we would be proud to be part of one of your projects.
Our services – best practices for your Clinical Research and Product-Development projects
We use our skills and extensive experience for the development of ambitious solutions for your projects. We employ a systematic and tailor-made approach and understand that the faster the outcome of the projects, the greater would be your advantage in the market.
Organised in six different categories, we provide our spot‑on services either as full-service or just parts of our portfolio. Whenever you require it, we are more than happy to serve you with our expertise in both the conduct and as a consultancy service.
For a comprehensive yet clear overview, further information is available by opening each of the categories below.
Clinical Research
Generation and compilation of clinical data through Clinical Trials compliant to GCP-standards.
Clinical Data Management
From capture to analysis – we ensure your data are of the highest quality, reliable and trustworthy.
Product Development
Professional advice and scientific guidance at all stages – we manage your pharmaceutical development.
Pharmacovigilance
Focussed on safety – we manage your drug safety obligations as a marketing authorisation holder.
Medical Writing
Precise and accurate – we develop and generate tailor-made
documentation.
Events – Looking forward to meet you soon
Nowadays, it has become a fashion to communicate online, and personal meetings are less frequent. At Mediconomics, we believe that, as human beings, we rely on personal interactions as an integral part of building a partnership and trust. Perhaps we could meet at one of the following conferences and learn more about you and the needs of your projects:
PLCD Spring Meeting
Heidelberg, Germany
April 25-26, 2023
OCT Europe 2023
Barcelona, Spain
May 03-04, 2023
BIO-Europe 2023
Munich, Germany
Nov 06-08, 2023
FAQ – frequently asked questions
By tailoring our services in Clinical Research, Regulatory Affairs, Pharmacovigilance and Medical Writing to your individual needs, we ensure that outsourcing of time-consuming and knowledge-intensive process steps is successful.
Your projects will benefit from our many years of experience, our expertise, our high standards, and proven best-practice processes, as well as our progressive way of thinking. We have summarised our client’s most frequently asked questions for you below. Feel free to use our contact options to clarify any further questions.
What are your areas of expertise?
Expert knowledge in Regulatory Affairs and Pharmacovigilance – keeping up with the cutting edge over the last 20 years
We specialise in Regulatory Affairs and provide you with comprehensive and reliable support in all matters relating to the topic of medicinal product marketing authorisation. Within the framework of regulatory affairs management, we ensure that all the necessary processes of your marketing authorisation procedure are carried out in a structured manner and with the utmost precision.
We ensure compliance with legal requirements that exist for the authorisation of your Medicinal Product or Medical Device. Our experts in Medical Device Law carry out all the necessary checks of legal conformity with regard to relevant regulations, standards and directives. We offer complete life-cycle management of the marketing authorisations of medicinal products and medical devices.
Why should I consider Mediconomics for my pharma project?
At Mediconomics, we combine medicine and science together with economic efficiency, and can therefore offer individualised and concise advice in our areas of expertise.
We are professional solution provider since 1999 and always managed to remain small enough to provide flexible solutions but large enough to deal with complex situations.
As an international company, we are your reliable partner even beyond national borders.
Interested? Contact us via phone or contact form today!
What characterises the area of Pharmacovigilance at Mediconomics?
Tailor-made solutions for Pharmacovigilance – Ensuring the safety of your medicinal products and Medical Devices
Monitoring the safety of Medicinal Products and Medical Devices – especially with regard to adverse effects – plays an important role in the EU and worldwide. A functioning risk management strategy and close cooperation with the competent national and international regulatory authorities (such as EMA and FDA) in the field of the use of Medicinal Products is indispensable. One of our core competences is Pharmacovigilance – i.e. developing and carrying out measures for the continuous and systematic monitoring of medicinal products.
We are also active in the development of Medical Devices and can support you as a service provider in adapting to the new requirements of the Medical Device Regulation (MDR).
Our experts comprehensively research, record and evaluate side effects and other problems associated with a Medicinal Product with careful precision. Whether defective compounds and packaging, errors in the manufacturing process or the communication of comprehensive information on a Medicinal Product – we support you in ensuring the safety of your Medicinal Product, in analysing side effects and in preventing errors in the application or therapy.
What is distinctive about your work in Clinical Research?
Preparing and conducting clinical trials – your Clinical Research Organisation for customised solutions.
Within the framework of clinical trials, we evaluate the quality, efficacy and safety of your medicinal products. Benefit from our many years of experience in planning and conducting clinical research and systematic evaluation. We specialise clinical trials of phases I-IV according to international standards and minimise risks through absolute compliance with all protective regulations. In addition to medical aspects, we examine the economic advantages of Medical Devices and drug innovations within the context of individual cost-benefit analyses. In this way, we create optimal conditions for the implementation of your development programme.
If desired, we have the capacity to take care of all steps of clinical research and product development and ensure that deadlines are reliably met. Throughout this process, we remain in consistent communication with the competent authorities and ethics committees.
Which services does Clinical Data Management cover at Mediconomics?
Your service provider for Clinical Data Management
Based on our many years of experience and expertise, we are your competent service provider for the data management of small and large-scale clinical trials. Our web-based IT systems for clinical data management ensure that we are capable of providing reliable data of impeccable quality.
We provide a professional eCRF setup (Electronic Case Report Form) and implement a software system for you that manages your clinical trial data in a clearly structured way. Our EDC Setup (Electronic Data Capture) guarantees the complete recording of the measurement results and other data – including image files and the integration of external data – in a secure online database. In combination with the eCRF setup, this creates the basis for a precise statistical evaluation.
Which services do you offer for Medical Writing?
Your Service Provider for Medical Writing
As a Medical Writing service provider, we prepare scientifically sound documents for clinical studies such as study designs, protocols, IB/IMPDs or final reports. Furthermore, our medical writers also provide support in the areas of Regulatory Affairs and Pharmacovigilance via the preparation of Expert Reports, Clinical Evaluation Reports, Biological Evaluation Reports and toxicological reports. Your projects can benefit from our expertise on specific issues relating to various active pharmaceutical ingredients.
Mediconomics Factsheet
Our focus:
Contract services and Pharma Consulting for Clinical Research with Medicinal Products, Medical Devices and development candidates as both full-service and single-service.
- Regulatory Affairs
- Clinical Research
- Clinical Data Management
- Pharmacovigilance
- Medical Writing
Projects overall:
170+ Clinical Research Projects
40+ Patente
Competence status:
20+ years of experience, certified acc. to DIN EN ISO 9001:2015, CTR 536/2014, German Medicinal Products Act, in-depth knowledge of GCP and GMP, patent law and up-to-date expertise.
Organised in:
German Federal Association of CROs (BVMA)
German Society for Regulatory Affairs (DGRA)
European Medical Writers Association (EMWA)
Research Association of Drug Manufacturers (FAH)
Institute of Clinical Research
Society for Clinical Data Management (SCDM)
US BIOCOM directory
You’re welcome.
Managing Director:
Dr. (MD) Uwe Albrecht,
FIBMS, MFPM (Dis.), FICR, CSci
Tel.: +49 (0) 511 560 998-0
How may we help you?
DE
Mediconomics GmbH
Misburger Straße 81 b
30625 Hannover
Germany
DK
mediconomics aps
Slotsbryggen 14 A-D
4800 Nykøbing F
Denmark
UK
mediconomics UK
Spring Farm House
Wallingford Rd
Goring On Thames
United Kingdom
US
mediconomics inc.
4141 1/2 Verdugo Road
Los Angeles CA 90065
USA
CH
mediconomics gmbh
Ringstraße 22
4600 Olten
Switzerland
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Contact
Tel: +49 (0) 511 560 9980
contact@mediconomics.com
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