Global coverage
Our customers (industry and regulatory authorities) are using READY! across the globe.
AET, Germany
Comprehensive Pharmaceutical Services
AET offers a comprehensive range of services, starting from API sourcing and encompassing development, including aspects of chemistry, galenics, and intellectual property. They continue their support through clinical trials, registration processes, and supply chain maintenance.
READY! Across Multiple Functions
In addition to its core function in Regulatory Affairs, READY! plays a pivotal role in AET’s development projects, aiding in various aspects of pharmaceutical R&D.
Furthermore, it is a valuable tool for efficient Article 57 reporting.
Aristo, Germany
About Aristo Pharma
Aristo Pharma is the result of a merger between several German medium-sized pharmaceutical companies, some with over a century of experience.
Committed to delivering high-quality medicines, Aristo Pharma focuses on ensuring readily available and affordable healthcare solutions.
Progressive Growth in Europe
Aristo Pharma has rapidly evolved into one of the most dynamic and fastest-growing pharmaceutical companies in Europe.
READY! plays a pivotal role in providing critical information about their products, registrations, and various regulatory activities, including variations.
Beyond Regulatory Affairs
In addition to its role in Regulatory Affairs, READY! is also instrumental in facilitating Article 57 reporting for Aristo Pharma.
mabXience, Spain
About mAbxience: Specializing in Biosimilar Monoclonal Antibodies
mAbxience is a leading biotechnology company with expertise in researching, developing, and manufacturing biosimilar monoclonal antibodies.
READY! for Biomedicines
As a fundamental component of its regulatory affairs capabilities, READY! serves as a versatile tool for the comprehensive management of product information within the biomedicines domain.
It facilitates various functions, including strategic planning for new registrations and the efficient tracking of variations and renewals.
Yonsung, South Korea
Yonsung, South Korea
Yonsung, based in South Korea, is dedicated to the development and sale of APIs , leveraging unparalleled technology and expertise in addition to drug substances.
READY! Enhancing API Registration and Monitoring
API production at Yonsung rely on READY! to streamline procedures related to API registrations and to monitor Clients activities and their Marketing Authorizations. Understanding how and where clients utilize and sell their APIs is crucial for every API produced.
Efficiency Through READY!
READY! has effectively replaced the need for cumbersome Excel spreadsheets, significantly enhancing the efficiency of the entire team.
Sandoz, Germany
Sandoz, a global leader in generic and biosimilar medicines, is committed to improving worldwide access to essential medications.
Streamlining Article 57 Reporting with READY!
Achievements:
- Since 2013, Sandoz has seamlessly processed over 1.000.000 XEVMPD messages for Article 57 reporting.
- READY! was installed and fully tested in just three months, making it the backbone of what is perhaps the largest Article 57 database installation in Europe.
- READY! efficiently handles data validation, processing, Article 57 submissions, and Acknowledgement management.
Project Overview:
- The EMA’s new regulation on Article 57 reporting presented a pressing need for implementation within tight timelines.
- Sandoz, being a major player in the pharmaceutical industry with a vast product portfolio, faced unique challenges.
- Integration with their existing SAP system was crucial, requiring tailored solutions that met their specific IT environment and needs.
- The solution needed to function as a gateway with built-in validation before submission.
Key Highlights:
- The project was a resounding success, completed within budget and on schedule.
- Nanokinetik provided READY! software integrated with an ESTRI gateway.
- Sandoz received expert implementation advice, computer validation support, and the assurance of meeting their quality objectives.
- The system has been operating smoothly since implementation.
- READY! enables Sandoz to efficiently submit a large volume of messages.
- Nanokinetik offers round-the-clock assistance for ongoing support.
Billevpharma, Denmark
Billev Pharma ApS is a Danish consultancy company operating within the international pharmaceutical and medical sectors. Pioneering in its field, the company was established in 1978 as the first of its kind in this region of Europe.
One of our first clients and ongoing success
Billev Pharma has been our valued client since the inception of READY! in 2012. They have harnessed READY! to address the intricate complexities of generic medicine regulations.
Moreover, READY! assists Billev Pharma in meticulously tracking time spent on customer projects, facilitating 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’s activities span the entire spectrum, from drug development to industrial manufacturing, consistently adhering to the highest quality and safety standards.
Their primary aim is to concentrate our efforts on the development and manufacturing of generic drugs with unique complexities.
These complexities may arise from the pharmaceutical challenges they present or their incompatibility with other product types.
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’s logo can be found on medicine boxes in pharmacies and hospitals not only in European countries but also around the world.
Their extensive distribution network ensures that our products reach pharmaceutical markets globally.
The drugs manufactured in their plants are marketed under their own brand names as well as under the brand names of licensed partners.
Cinfainnova, Spain
About Cinfa Innova
Cinfa Innova serves as the innovation and R&D center of the Cinfa Group. Specializing in the development of niche products, they focus on areas such as Women’s Health, Men’s Health, Gynecology, Oncology, and Endocrinology, among others.
READY! in Action
Cinfa Innova has been successfully utilizing 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.
