We develop, implement, and maintain validated medicinal product databases, tracking tools, and document management systems with a focus on the pharmaceutical industry and ISO IDMP standards.
More than 100 pharmaceutical companies and regulatory agencies are using our innovative solutions to safely create and manage medicinal product information, and track activities, documents, and electronic submissions efficiently and transparently.
By using our products and services they significantly reduce the risks of non-compliance and improve internal communications, as well as those with partners.
READY! is being used around the globe.
In addition to the countries in the European Union, our clients are using READY! in many countries including: India, Russia, the USA, China, the Ukraine, Argentina, Mexico, Brazil, Cambodia, Chile, Indonesia, Kazakhstan, Malaysia, Morocco, Paraguay, Philippines, Singapore, Thailand, Vietnam, etc.
Our skills and services:
- 20 years of practical experience in the pharmaceutical industry
- Practical knowledge of registering medicinal products and medical devices
- Deep understanding of the regulatory landscape and its complex environment
- Deep understanding of the XEVMPD and the dramatic consequences that ISO IDMP and the new pharmacovigilance legislation is bringing to the pharmaceutical industry
- A practical, hands-on approach to IT technology
- Design, development, implementation, validation, and maintenance of IT solutions for the pharmaceutical industry
- Pro-active help for companies in implementing various IT systems
- A clear view and understanding of the needs of pharmaceutical companies
- Extensive experience with the validation of IT systems according to FDA 21 CFR Part 11 and EU Annex 11
From the annual customer satisfaction surveys: