References
Global coverage
In addition to the countries in the European Union, READY! is being used around the globe:
The USA, India, Russia, China, Ukraine, Argentina, Mexico, Brazil, Chile, Indonesia, Kazakhstan, Malaysia, Philippines, Singapore, Thailand, Canada, and many others.
EDQM, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a directorate of the Council of Europe. Its origins date back to 1964.
The mission of the EDQM is to contribute to the basic human right of access to good quality medicines and healthcare, and to contribute to promoting and protecting human and animal health.
EDQM is implementing READY! to handle CEP certification process and support performing global inspections.
The project will be finished in Q2 2021.
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.
mabXcience, 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.
Automatic alerts are sent for important dates such as 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 both, procedures related to registrations of APIs to monitoring their 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! will replace all those Excel spreadsheets and increase efficiency of the whole team.
Chemo, Spain
With over 1,000 clients among top pharmaceutical companies worldwide, CHEMO holds a position of leading company in industry, developing and manufacturing added-value active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs), both for human and animal health, in all mayor therapeutics (Cardiovascular, Gastroenterology, Central Nervous System, Anti-infective, Respiratory, Women`s Healthcare, Endocrinology, Dermatology and Urology).
Installation in Chemo is holding tens of thousands products, APIs and Finished products.
The solution is tightly integrated with other vital IT systems and is used also for Article 57 reporting.
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
Exeltis, Spain
Exeltis is a consolidated, global organisation which operates through a network of more than 40 subsidiaries, employing close to 4,000 professionals across over 40 countries. Thay create solutions for Women's Health and other priorities such as Respiratory, Dermatology and Endocrinology.
Billevpharma, Denmark
Billev Pharma ApS is a Danish consultancy company within the international pharmaceutical and medical field. Billev Pharma ApS 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 of more than 72 products and 7.400 marketing authorisations worldwide.
PharOS has been using READY! since...
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 Pharma bases its activities upon the manufacturing and development of steroid based generic drugs.
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.
Today, our presence extends to over 80 countries through our collaboration with some of the most respected pharmaceutical companies in the world.
Nordic Group, France
Nordic Group is a privately owned pan-European pharmaceutical company with a presence in 17 countries. It focuses on the development and commercialization of niche hospital, and orphan products.
Nordic Group decided to implement READY! tools to be a part of its company development and European expansion.
READY! tools were chosen from other competitors after a strong selection and evaluation process.
The tools are extremely robust, very user-friendly, and allow quick customization and implementation.
Nanokinetik proactively helps Nordic to constantly maintain the validated status.
In addition to Regulatory Affairs department, READY! is being used in Nordic to handle mockups, agreements and QA processes including CAPA, deviations and global SOP management.
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.
DrReddys, UK
Generic Formulations, including tablets, capsules, injectables, and topical creams, is the largest part of DrReddys business portfolio, making products across the major therapeutic areas of gastrointestinal ailments, cardiovascular disease, pain management, oncology, anti-infective, pediatrics and dermatology.
DrReddys is using READY! for Article 57 from early beginnings.
Dr. Reddy's has decided to implement “READY!” for the purposes of XEVMPD reporting to the EMA Gateway.
READY! has been successfully implemented within the agreed scope, time, and resources necessary for the implementation.
READY! is web-based and has enabled Dr. Reddy's to easily access, manage, and submit medicinal product information from various geographic locations.
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.
Disphar, The Netherlands
Disphar International is fully focused on the development and licensing out of pharmaceutical products.
Integrated product database and document management.