READY! is a web-based solution based on IDMP standards that enables pharmaceutical companies to manage their medicinal product information, safety data, and documents in one validated environment.
Implementing READY! enables your team to work remotely.
Pharmaceutical companies and regulatory agencies use our software ‘READY!‘ to get rid of all of those Excel spreadsheets, outdated regulatory databases, and paper-based documents.
READY! is based on IDMP standards and serve as a single source of information on all products and related activities. Instead of unproductive time spent populating Excel spreadsheets, users of READY! can focus on their scientific work.
This translates into more work done with less stress.
READY! is not replacing project management tools in Development department.
It is being used to track development process and to store the results and documents . The documents and all information gathered and produced can be accessed by regulatory team in getting Marketing Approvals.
The combining of a Product Database and a Document Management System allows READY! to integrate the management of processes, documents, and products into one integrated platform – which is shared among business functions, including: QA, RA, R&D, PhV, and Production.
Medicine’s Product information (PI) is a pivotal source of regulated and scientifically validated information that assists in prescribing and dispensing the medicine and informs patients and consumers about its safe use.
Authorized, statutory product information for medicines include:
Summary of product characteristics (SmPC, intended for healthcare professionals)
Thank you for the outstanding support during 2013. We had very good experience by implementing the new release.
We never regretted our choice of the database provider!
READY! is a key tool for our RA department, since it really meets our expectations and needs. My main contact is an absolute professional with great expertise, who is always available to assist us with any question that we may have. I am very happy with your product and service and would like to congratulate the Nanokinetik team for your great work.
Continue with this incredible work you are providing to your customers. Thank you.
I never regret the choice my company maid to select Nanokinetik and their tools!
Excellent cooperation and willingness to resolve outstanding issues.
The READY! Database is meeting all of our expectations and needs, and I can speak for the whole team by saying that we are very happy with the tool, and especially with the excellent customer care that your team provides to us. We are in the process of inserting/reviewing data and hope to launch it internally.
Professional approach with appropriate solutions provided are appreciated as well as very important from customer view.
I have been working with you for more than six months and it seems to me that you have a very well defined and organised structure. The management of tickets is impeccable and the treatment is exemplary.
So far we have been very happy with our collaboration, and I am convinced that it will continue in 2020 (and beyond).
READY! stands for: REgulated Affairs DiarY
The complexity of managing information is simply reduced to an integrated product database and document management software.
The user interface is web-based and users simply like it.
READY! enables paperless work including electronic signatures of documents.
Implementing READY! enables your team to work remotely.
Since its creation, the structure of READY! and controlled vocabularies have been based on the ISO IDMP/SPOR standards. So, our existing and new clients will have no problem using READY! for Article 57 reporting based on the ISO IDMP Implementation Guide.
Our existing clients report an estimated 20% increase in their overall efficiency using READY!. This can be translated into 20% more scientific work done, instead of handling Excel spreadsheets, and can be measured with the salaries of an additional 20% of staff.
Your investment in READY! is returned in less than one year!
Over 20 years of experience providing the pharmaceutical industry with comprehensive software solutions and high-quality services.
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.
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 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 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.
READY! software with a built-in ESTRI gateway
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
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 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.”
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.
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 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 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.
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.