Global coverage
Our customers (industry and regulatory authorities) are using READY! across the globe.
AET, Germany
AET offers a comprehensive service from API sourcing, development including chemical, galenical and intellectual property aspects through clinical trials and registration to supply and maintenance.
Aristo, Germany
Originating from the merger of various German medium-sized pharmaceutical companies, some with 110 years of experience, Aristo Pharma are committed to providing high-quality medicines on a readily available and affordable basis.
Aristo is one of the most progressive and fast growing pharmaceutical companies in Europe. READY! is providing vital information about their products, registrations and other regulatory activities, including variations.
In addition to use in Regulatory affairs READY! is used also for Article 57 reporting.
mabXience, Spain
mAbxience is a biotechnology company specialized in the research, development and manufacture of biosimilar monoclonal antibodies.
Biomedicines can also be managed with READY!. All kinds of information, from planning new registrations to tracking variations and renewals.
Yonsung, South Korea
Along with drug substances, Yonsung works tirelessly to develop and sell drug products based on unparalleled technology and know-how.
API producers are using READY! to track procedures related to registrations of APIs and monitoring clients and their marketing authorisations. For every API produced it is essential to know what ther clients are doing and where are their APIs used and sold.
READY! replaced all those Excel spreadsheets and increased efficiency of the whole team.
Billev Pharma East, Slovenia
Although small it is one of the most complex environments.
READY! is being used for all kinds purposes, from archiving documents and tracking electronic submissions to pharmacovigilance and regulatory activities.
Sandoz, Germany
Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
Since 2013 Sandoz has seamlessly procesesed more than 500.000 XEVMPD messages for Article 57 reporting.
Installed and tested in only 3 months, READY! is seamlessly providing data validation, processing, Article 57 subbmissions and Acknowledges management in what is probably the largest Article 57 database installation in Europe.
About the project
The new regulation from the EMA regarding Article 57 and the mandatory submission of complex information about a large number of medicinal products has meant a dramatic shortage of implementation time.
Sandoz, one of the largest companies in the pharmaceutical industry, had an even greater challenge because they have such a vast product portfolio. Sandoz needed to integrate the solution with their existing systems – this is an additional challenge because out-of-the-box solutions had to meet their specific needs and IT environment.
The solution had to be a gateway solution with built-in validation prior to actual submission.
They had to choose the best system that meets all of these requirements, that could be implemented quickly, and according to the highest standards.
The project was finished highly successfully, on-budget, and on time.
Nanokinetik provided:
- READY! software with a built-in ESTRI gateway
- On-time delivery
- Implementation advice
- Computer validation
- The capability to meet their quality objectives
- A dependable system that was up, and is still running without a hitch
- A system to submit a large number of messages
- Assistance 24/7
Billevpharma, Denmark
Billev Pharma ApS is a Danish consultancy company within the international pharmaceutical and medical field. It was set up in 1978 as the first company of its kind in this part of Europe.
Billev pharma was our first client. They are solving problems in the complex environment of generic medicine regulations using READY! since 2012. READY! is also being used to track time spent for the customers, providing automatic monthly invoicing.
PharOS, Greece
PharOS is a privately owned pharmaceutical company, developing, manufacturing and supplying generics and value added products with a global portfolio.
PharOS has been using READY! since 2012.
It represents a vital tool for management all various tasks and activities. Is also integrated with Document management and used for Article 57 reporting.
“We have decided to implement READY! after careful analysis of the solution and the benefits of implementing it. READY! has replaced our spreadsheets and is providing up-to-date information about all our medicinal products, documents, and on-going regulatory activities in the company. READY! also integrated with EMC/Documentum, our document management system.
We are happy with the solution and the services Nanokinetik is providing to PharOS.”
Stella Koukaki
Managing Director/Pharmaceutical Oriented Services Ltd.
Cyndea, Spain
Cyndea activities range from drug development to industrial manufacturing, always under the most stringent and demanding quality and safety standards.
It aims to focus its efforts on the development and manufacturing of generic drugs associated with a distinctive complexity, either due to their difficulty to develop pharmaceutically, or due to their handling incompatibility with other types of products.
Genepharm, Greece
While GENEPHARM retains its position in the Greek market, having established solid relationships with local physicians and patients, our business extends globally via strategic alliances, based on the development of new products and our continuous investment in state-of-the-art infrastructure and technologies.
JGL, Croatia
JGL is one of the leading producers of sterile ear, nose and eye products in the European Union.
For many years JGL is using READY! Gateway for the purposes of handling and submitting product information according to Article 57 regulation.
RAFARM, Greece
RAFARM logo is found on the medicine boxes in pharmacies and hospitals in European countries and countries all over the world.
Through our extensive distribution network, our products reach pharmaceutical markets around the world.
The drugs produced in our manufacturing plant are marketed under our own brand names and also under the brand names of our licenses.
Cinfainnova, Spain
Cinfa Innova is the innovation and R&D’s center of Cinfa Group. Cinfa Innova specializes in the development of niche products including areas as Women Health, Male Health, Gynecology, Oncology and Endocrinology among others.
Cinfainova has been succesfully using READY! since 2015.
… and many others …
READY! SOLUTIONS
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READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
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Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
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Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
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Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
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Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
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Development
Track milestones and store documents created in the development of a new medicine.
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Quality Assurance
Manage processes, documents, and products in one integrated platform.
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Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
READY!® stands for: REgulated Affairs DiarY
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.
